Explore opportunities in clinical research, a field dedicated to advancing healthcare through scientific investigation. Clinical research jobs involve designing and conducting studies to evaluate the safety and efficacy of new treatments, therapies, and diagnostic tools. Professionals in this sector play a crucial role in collecting and analyzing data, ensuring regulatory compliance, and contributing to medical breakthroughs.11,571 Clinical Research jobs in the United States
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Clinical Research Coordinator
78202 Fort Sam Houston, Texas
U.S. Renal Care
Posted today
Job Viewed
Job Description
SUMMARY
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
- Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
- Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
- Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
- Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
- Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
- Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
- Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
- Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
- Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
- Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
- Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
- Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
- Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
- Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
- Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
- Adheres to the USRC Research quality assurance program guidelines.
- Travel to Investigator Meetings or similar research related meetings is required.
- Travel may be required between dialysis facilities or nephrology practices within the community.
- Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
- May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
- Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
- Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
- Participate in staff meetings as required.
- Regular and reliable attendance is required for the job.
- Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
- Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
- Regular and reliable attendance is required for the job.
Qualifications/Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements include:
- Bachelor's degree in related field preferred.
- One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
- Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
- Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
- Strong verbal and written communication skills required.
- Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
All Full Time employees are eligible for the following benefits: * Medical / Pharmacy * Dental * Vision * Voluntary benefits * 401k with employer match * Virtual Care * Life Insurance * Voluntary Benefits * PTO All Part Time employees are eligible for the following benefits: * 401k with employer match * PTO
View Now
0
Clinical Research Coordinator
33912 Fort Myers, Florida
U.S. Renal Care
Posted today
Job Viewed
Job Description
SUMMARY
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
- Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
- Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
- Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
- Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
- Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
- Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
- Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
- Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
- Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
- Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
- Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
- Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
- Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
- Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
- Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
- Adheres to the USRC Research quality assurance program guidelines.
- Travel to Investigator Meetings or similar research related meetings is required.
- Travel may be required between dialysis facilities or nephrology practices within the community.
- Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
- May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
- Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
- Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
- Participate in staff meetings as required.
- Regular and reliable attendance is required for the job.
- Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
- Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
- Regular and reliable attendance is required for the job.
Qualifications/Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements include:
- Bachelor's degree in related field preferred.
- One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
- Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
- Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
- Strong verbal and written communication skills required.
- Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
All Full Time employees are eligible for the following benefits: * Medical / Pharmacy * Dental * Vision * Voluntary benefits * 401k with employer match * Virtual Care * Life Insurance * Voluntary Benefits * PTO All Part Time employees are eligible for the following benefits: * 401k with employer match * PTO
View Now
1
Clinical Research Coordinator
78202 San Antonio, Texas
U.S. Renal Care
Posted today
Job Viewed
Job Description
SUMMARY
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
- Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
- Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
- Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
- Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
- Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
- Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
- Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
- Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
- Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
- Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
- Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
- Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
- Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
- Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
- Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
- Adheres to the USRC Research quality assurance program guidelines.
- Travel to Investigator Meetings or similar research related meetings is required.
- Travel may be required between dialysis facilities or nephrology practices within the community.
- Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
- May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
- Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
- Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
- Participate in staff meetings as required.
- Regular and reliable attendance is required for the job.
- Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
- Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
- Regular and reliable attendance is required for the job.
Qualifications/Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements include:
- Bachelor's degree in related field preferred.
- One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
- Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
- Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
- Strong verbal and written communication skills required.
- Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
All Full Time employees are eligible for the following benefits: * Medical / Pharmacy * Dental * Vision * Voluntary benefits * 401k with employer match * Virtual Care * Life Insurance * Voluntary Benefits * PTO All Part Time employees are eligible for the following benefits: * 401k with employer match * PTO
View Now
2
Clinical Research Coordinator
33912 Fort Myers, Florida
U.S. Renal Care
Posted today
Job Viewed
Job Description
SUMMARY
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
- Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
- Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
- Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
- Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
- Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
- Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
- Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
- Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
- Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
- Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
- Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
- Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
- Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
- Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
- Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
- Adheres to the USRC Research quality assurance program guidelines.
- Travel to Investigator Meetings or similar research related meetings is required.
- Travel may be required between dialysis facilities or nephrology practices within the community.
- Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
- May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
- Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
- Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
- Participate in staff meetings as required.
- Regular and reliable attendance is required for the job.
- Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
- Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
- Regular and reliable attendance is required for the job.
Qualifications/Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements include:
- Bachelor's degree in related field preferred.
- One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
- Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
- Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
- Strong verbal and written communication skills required.
- Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
All Full Time employees are eligible for the following benefits: * Medical / Pharmacy * Dental * Vision * Voluntary benefits * 401k with employer match * Virtual Care * Life Insurance * Voluntary Benefits * PTO All Part Time employees are eligible for the following benefits: * 401k with employer match * PTO
View Now
3
Clinical Research Coordinator
33912 Fort Myers, Florida
U.S. Renal Care
Posted today
Job Viewed
Job Description
SUMMARY
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
- Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
- Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
- Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
- Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
- Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
- Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
- Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
- Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
- Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
- Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
- Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
- Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
- Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
- Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
- Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
- Adheres to the USRC Research quality assurance program guidelines.
- Travel to Investigator Meetings or similar research related meetings is required.
- Travel may be required between dialysis facilities or nephrology practices within the community.
- Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
- May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
- Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
- Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
- Participate in staff meetings as required.
- Regular and reliable attendance is required for the job.
- Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
- Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
- Regular and reliable attendance is required for the job.
Qualifications/Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements include:
- Bachelor's degree in related field preferred.
- One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
- Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
- Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
- Strong verbal and written communication skills required.
- Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
View Now
4
Clinical Research Coordinator
33912 Fort Myers, Florida
U.S. Renal Care
Posted 1 day ago
Job Viewed
Job Description
SUMMARY
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
- Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
- Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
- Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
- Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
- Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
- Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
- Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
- Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
- Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
- Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
- Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
- Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
- Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
- Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
- Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
- Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
- Adheres to the USRC Research quality assurance program guidelines.
- Travel to Investigator Meetings or similar research related meetings is required.
- Travel may be required between dialysis facilities or nephrology practices within the community.
- Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
- May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
- Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
- Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
- Participate in staff meetings as required.
- Regular and reliable attendance is required for the job.
- Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
- Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
- Regular and reliable attendance is required for the job.
Qualifications/Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements include:
- Bachelor's degree in related field preferred.
- One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
- Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
- Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
- Strong verbal and written communication skills required.
- Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.
View Now
5
Clinical Research Coordinator
71133 Shreveport, Louisiana
Ochsner Health
Posted 2 days ago
Job Viewed
Job Description
**We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate,** **and innovate. We believe** **that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.**
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job evaluates initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at Ochsner's discretion.
**Education**
Required - High School diploma or equivalent
**Work Experience**
Required - 3 years of relevant research experience in a clinical setting,
OR
2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification.
**Certifications**
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
**Knowledge Skills and Abilities (KSAs)**
+ Must have computer skills and dexterity required for data entry and retrieval of patient information. Must be proficient with Windows-style applications and keyboard.
+ Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
+ Must have computer skills and dexterity required for data entry and retrieval of information
+ Must be proficient with Windows-style applications, various software packages specific to role and keyboard
**Job Duties**
- Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
- Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
- Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
- Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
- Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
- Supports department, division, and institutional goals.
Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.
Complies with the Ochsner Health System Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
Ochsner is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.
Normal routine involves no exposure to blood, body fluid or tissue and as part of their employment, incumbents are not called upon to perform or assist in emergency care or first aid.
There is no occupational risk for exposure to communicable diseases.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
**_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at (select option 1) or_** ** ** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job evaluates initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at Ochsner's discretion.
**Education**
Required - High School diploma or equivalent
**Work Experience**
Required - 3 years of relevant research experience in a clinical setting,
OR
2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification.
**Certifications**
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
**Knowledge Skills and Abilities (KSAs)**
+ Must have computer skills and dexterity required for data entry and retrieval of patient information. Must be proficient with Windows-style applications and keyboard.
+ Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
+ Must have computer skills and dexterity required for data entry and retrieval of information
+ Must be proficient with Windows-style applications, various software packages specific to role and keyboard
**Job Duties**
- Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
- Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
- Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
- Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
- Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
- Supports department, division, and institutional goals.
Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.
Complies with the Ochsner Health System Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
Ochsner is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.
Normal routine involves no exposure to blood, body fluid or tissue and as part of their employment, incumbents are not called upon to perform or assist in emergency care or first aid.
There is no occupational risk for exposure to communicable diseases.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
**_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at (select option 1) or_** ** ** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
View Now
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6
Clinical Research Coordinator
71201 Monroe, Louisiana
Ochsner Health
Posted 2 days ago
Job Viewed
Job Description
**We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate,** **and innovate. We believe** **that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.**
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job evaluates initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at Ochsner's discretion.
**Education**
Required - High School diploma or equivalent
**Work Experience**
Required - 3 years of relevant research experience in a clinical setting,
OR
2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification.
**Certifications**
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
**Knowledge Skills and Abilities (KSAs)**
+ Must have computer skills and dexterity required for data entry and retrieval of patient information. Must be proficient with Windows-style applications and keyboard.
+ Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
+ Must have computer skills and dexterity required for data entry and retrieval of information
+ Must be proficient with Windows-style applications, various software packages specific to role and keyboard
**Job Duties**
- Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
- Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
- Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
- Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
- Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
- Supports department, division, and institutional goals.
Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.
Complies with the Ochsner Health System Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
Ochsner is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.
Normal routine involves no exposure to blood, body fluid or tissue and as part of their employment, incumbents are not called upon to perform or assist in emergency care or first aid.
There is no occupational risk for exposure to communicable diseases.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
**_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at (select option 1) or_** ** ** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job evaluates initiates and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned area(s) of responsibility.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at Ochsner's discretion.
**Education**
Required - High School diploma or equivalent
**Work Experience**
Required - 3 years of relevant research experience in a clinical setting,
OR
2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification.
**Certifications**
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
**Knowledge Skills and Abilities (KSAs)**
+ Must have computer skills and dexterity required for data entry and retrieval of patient information. Must be proficient with Windows-style applications and keyboard.
+ Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
+ Must have computer skills and dexterity required for data entry and retrieval of information
+ Must be proficient with Windows-style applications, various software packages specific to role and keyboard
**Job Duties**
- Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
- Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
- Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
- Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
- Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
- Supports department, division, and institutional goals.
Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.
Complies with the Ochsner Health System Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
Ochsner is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized.
Must be able to sit for prolonged periods of time.
Must be able to travel throughout and between facilities.
Must be able to work a flexible work schedule.
Normal routine involves no exposure to blood, body fluid or tissue and as part of their employment, incumbents are not called upon to perform or assist in emergency care or first aid.
There is no occupational risk for exposure to communicable diseases.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
**_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at (select option 1) or_** ** ** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
View Now
7
Clinical Research Coordinator
60805 Evergreen Park, Illinois
Actalent
Posted 2 days ago
Job Viewed
Job Description
Job Title: Clinical Research Coordinator
Job Description
We are seeking a dedicated Clinical Research Coordinator to join our dynamic team. The ideal candidate will play a crucial role in the coordination and execution of clinical trials, ensuring compliance with all relevant guidelines and protocols.
Responsibilities
+ Recruit and screen patients for clinical studies.
+ Execute Informed Consent Forms in alignment with ICH and GCP guidelines.
+ Conduct assessments during study visits according to the study protocol and document these visits accurately.
+ Perform phlebotomy and process, ship blood and urine samples as per protocol requirements.
+ Enter source document data into the respective EDC vendor system and respond to queries promptly.
+ Perform vital signs checks, ECGs, and other assessments required by the protocol.
+ Record adverse events and serious adverse events as per sponsor guidance and maintain timely follow-up.
+ Monitor, dispense, and collect investigational products; maintain accountability and temperature logs, and report any temperature excursions.
+ Schedule, prepare, and conduct visits such as SIV, IMVs, and COV with the sponsor/CRO team.
Essential Skills
+ Pre-screening patients
+ Clinical research
+ Clinical trial management
+ Patient recruitment
+ Project management
+ GCP certification
+ IATA certification
Work Environment
The work environment for this role is collaborative and focused on ensuring the highest standards of clinical trial conduct. You will work with advanced electronic data capture systems and be part of a team that is committed to improving patient outcomes through research. The role may require handling biological samples and working with investigational products in a regulated setting.
Pay and Benefits
The pay range for this position is $35.00 - $38.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Evergreen Park,IL.
Application Deadline
This position is anticipated to close on Nov 3, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
Job Description
We are seeking a dedicated Clinical Research Coordinator to join our dynamic team. The ideal candidate will play a crucial role in the coordination and execution of clinical trials, ensuring compliance with all relevant guidelines and protocols.
Responsibilities
+ Recruit and screen patients for clinical studies.
+ Execute Informed Consent Forms in alignment with ICH and GCP guidelines.
+ Conduct assessments during study visits according to the study protocol and document these visits accurately.
+ Perform phlebotomy and process, ship blood and urine samples as per protocol requirements.
+ Enter source document data into the respective EDC vendor system and respond to queries promptly.
+ Perform vital signs checks, ECGs, and other assessments required by the protocol.
+ Record adverse events and serious adverse events as per sponsor guidance and maintain timely follow-up.
+ Monitor, dispense, and collect investigational products; maintain accountability and temperature logs, and report any temperature excursions.
+ Schedule, prepare, and conduct visits such as SIV, IMVs, and COV with the sponsor/CRO team.
Essential Skills
+ Pre-screening patients
+ Clinical research
+ Clinical trial management
+ Patient recruitment
+ Project management
+ GCP certification
+ IATA certification
Work Environment
The work environment for this role is collaborative and focused on ensuring the highest standards of clinical trial conduct. You will work with advanced electronic data capture systems and be part of a team that is committed to improving patient outcomes through research. The role may require handling biological samples and working with investigational products in a regulated setting.
Pay and Benefits
The pay range for this position is $35.00 - $38.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Evergreen Park,IL.
Application Deadline
This position is anticipated to close on Nov 3, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now
8
Clinical Research Coordinator
60453 Oak Lawn, Illinois
Actalent
Posted 2 days ago
Job Viewed
Job Description
Job Title: Research Coordinator
Job Description
The Research Coordinator will support the implementation of research studies by assisting with tasks such as recruitment, data collection, data management, and reporting results. This role involves working closely with an Investigator, Research Associate, or Project Manager to ensure the smooth execution of research activities.
Responsibilities
+ Recruit and consent research participants.
+ Conduct telephone or in-person interviews with participants, including screening for eligibility.
+ Perform follow-up with study participants via telephone, e-mail, and/or mail.
+ Prepare, mail, and process questionnaires and other study correspondence.
+ Assist in tracking study participants using MS Excel.
+ Maintain accurate and detailed records and files of work.
+ Review, edit, clean, and enter participant data into a database.
+ Assist with literature reviews for proposal submissions and manuscript preparation.
+ Manage bookkeeping related to study budgets, including ordering supplies and requesting payments and participant incentives.
+ Perform miscellaneous administrative tasks such as typing labels, copying, faxing, meeting preparation, note-taking, and transcribing audio files.
Essential Skills
+ High school diploma or General Education Development (GED).
+ Minimum of 6 months of clinical research experience.
+ Background in the medical field, including phlebotomy and vaccines.
Additional Skills & Qualifications
+ Tech savvy.
+ Interest in growing in Clinical Research.
+ Data entry skills.
Pay and Benefits
The pay range for this position is $25.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Oak Lawn,IL.
Application Deadline
This position is anticipated to close on Nov 3, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
Job Description
The Research Coordinator will support the implementation of research studies by assisting with tasks such as recruitment, data collection, data management, and reporting results. This role involves working closely with an Investigator, Research Associate, or Project Manager to ensure the smooth execution of research activities.
Responsibilities
+ Recruit and consent research participants.
+ Conduct telephone or in-person interviews with participants, including screening for eligibility.
+ Perform follow-up with study participants via telephone, e-mail, and/or mail.
+ Prepare, mail, and process questionnaires and other study correspondence.
+ Assist in tracking study participants using MS Excel.
+ Maintain accurate and detailed records and files of work.
+ Review, edit, clean, and enter participant data into a database.
+ Assist with literature reviews for proposal submissions and manuscript preparation.
+ Manage bookkeeping related to study budgets, including ordering supplies and requesting payments and participant incentives.
+ Perform miscellaneous administrative tasks such as typing labels, copying, faxing, meeting preparation, note-taking, and transcribing audio files.
Essential Skills
+ High school diploma or General Education Development (GED).
+ Minimum of 6 months of clinical research experience.
+ Background in the medical field, including phlebotomy and vaccines.
Additional Skills & Qualifications
+ Tech savvy.
+ Interest in growing in Clinical Research.
+ Data entry skills.
Pay and Benefits
The pay range for this position is $25.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Oak Lawn,IL.
Application Deadline
This position is anticipated to close on Nov 3, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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