2,204 Clinical Research Coordinator jobs in the United States

Clinical Research Coordinator - Medicine Clinical Trials Office

10176 New York, New York Mount Sinai Health System

Posted 16 days ago

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Job Description

**Job Description**
The Clinical Research Coordinator is an entry human subjects researcher, responsible for conducting and assisting in clinical research studies under the supervision of the Principal Investigator or senior clinical research staff. This individual obtains informed consent, collects, maintains and organizes study information. Assists in the preparation and submission of grant applications and documents (e.g., Institutional Review Board, Grants and Contracts Office).
**Qualifications**
+ Bachelors degree in science or related field preferred or a combination of relevant research experience and education
+ 0-2 years of research/human subjects experience
**Responsibilities**
+ Conducts routine and standardized human subjects research using appropriate research or interview techniques specific to subject matter of the research project, under direct supervision of the Principal Investigator or senior clinical research staff.
+ Assists in the activities related to clinical research including, but not limited to: obtaining informed consent, screening participants for eligibility, registering patients with sponsoring agencies, administering questionnaires and answering telephone calls.
+ Assists in the collection, analysis and review of experimental data for publication and presentation.
+ Maintains source documents and subject files in accordance with Mount Sinai policies and procedures. Ensures accurate, confidential and complete compilation of data.
+ May secure and ship clinical specimens as required by the protocol.
+ May assist in the preparation for regulatory agency site visits.
+ Performs other related duties
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $16.5 - $ Hourly. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
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Clinical Research Coordinator I - Medicine Clinical Trials Office

10176 New York, New York Mount Sinai Health System

Posted 16 days ago

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Job Description

**Job Description**
The Clinical Research Coordinator assists in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information. Assists in preparing grant applications and documents (for e.g., Institutional Review Board, Grants and Contracts Office).
**Qualifications**
+ Bachelors or Masters degree in Science or closely related field.
+ 1-2 years of research experience
**Responsibilities**
+ Collects and records study data. Inputs all information into database.
+ Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
+ Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
+ Assists in preparing grant applications, IRB/GCO for submission and filings.
+ Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.
+ Secures, delivers and ships clinical specimens as required by the protocol.
+ Prepares for monitoring visits.
+ Performs other related duties.
**About Us**
**Strength through Unity and Inclusion**
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
**About the Mount Sinai Health System:**
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
**Equal Opportunity Employer**
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.
**Compensation Statement**
Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $58661 - $73530 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
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Clinical Research Coordinator, Oncology Trials

92101 San Diego Country Estates, California $75000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a leading academic medical center renowned for its groundbreaking cancer research, is seeking a dedicated and highly organized Clinical Research Coordinator to manage and support complex oncology clinical trials. This vital role will be instrumental in ensuring the efficient and ethical execution of studies, contributing to advancements in cancer treatment. You will be responsible for a broad range of activities, including patient recruitment and screening, informed consent processes, data collection and management, and study-related procedures. This position requires a deep understanding of clinical trial protocols, regulatory requirements (e.g., FDA, ICH-GCP), and patient care principles. The ideal candidate will possess excellent interpersonal skills to effectively communicate with patients, physicians, research staff, and regulatory agencies. Meticulous attention to detail is paramount for accurate data entry and documentation. You will also be involved in monitoring patient safety, managing investigational products, and ensuring compliance with all study protocols and institutional policies. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is highly desirable. This is a remote-first role, offering the flexibility to manage your work from home, with occasional visits to the research site in San Diego, California, US , for critical patient interactions or team meetings as needed. You must be self-motivated, possess strong organizational and time-management skills, and be able to work independently while collaborating effectively with a remote team. This is an exceptional opportunity to contribute to life-saving research, work alongside leading oncologists and researchers, and make a tangible difference in the lives of cancer patients. We are seeking a compassionate and driven professional committed to the highest standards of clinical research ethics and practice.
Key Responsibilities:
  • Coordinate all aspects of assigned clinical trials, from initiation to close-out.
  • Recruit, screen, and enroll eligible patients into clinical trials.
  • Obtain informed consent from participants and ensure protocol adherence.
  • Collect, process, and manage study-related data accurately and efficiently.
  • Monitor patient safety and adverse events, reporting them per protocol.
  • Administer study medications and conduct study-related procedures.
  • Maintain all study-related documentation, including regulatory binders and source documents.
  • Liaise with investigators, research staff, sponsors, and regulatory agencies.
  • Ensure compliance with all applicable regulations and guidelines (GCP, FDA).
  • Manage investigational product accountability and storage.
  • Prepare for and participate in site visits from sponsors and regulatory auditors.
  • Contribute to protocol development and study design when required.
Qualifications:
  • Associate's or Bachelor's degree in Nursing, Life Sciences, or a related field.
  • 3+ years of experience as a Clinical Research Coordinator, preferably in oncology.
  • Current RN license or equivalent clinical background is a strong asset.
  • Proficiency in Good Clinical Practice (GCP) guidelines and regulatory requirements.
  • Experience with Electronic Data Capture (EDC) systems (e.g., REDCap, Medidata Rave).
  • Excellent organizational, time management, and multitasking skills.
  • Strong communication, interpersonal, and patient interaction skills.
  • Ability to work independently and as part of a remote team.
  • Proficiency in Microsoft Office Suite.
  • Detail-oriented with a high level of accuracy.
  • Passion for medical research and patient care.
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Clinical Research Coordinator

33912 Fort Myers, Florida U.S. Renal Care

Posted today

Job Viewed

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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.
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Clinical Research Coordinator

33912 Fort Myers, Florida U.S. Renal Care

Posted today

Job Viewed

Tap Again To Close

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

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Clinical Research Coordinator

33912 Fort Myers, Florida U.S. Renal Care

Posted 1 day ago

Job Viewed

Tap Again To Close

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

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Clinical Research Coordinator

Wyomissing, Pennsylvania The Judge Group

Posted today

Job Viewed

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Job Description

Clinical Research Coordinator

The Clinical Research Coordinator supports the Research Department by facilitating subject recruitment, managing data workflows, and coordinating the collection and processing of biological specimens and study-related documentation.

Responsibilities

  • Organize research files, projects, and data to support study operations.
  • Collect, process, and verify research data, samples, and specimens in accordance with study protocols.
  • Enter and maintain accurate data in databases and study documents.
  • Perform routine data quality checks to ensure protocol compliance and data integrity.
  • Review and adhere to standard operating procedures (SOPs) and study protocols.
  • Notify referring physicians of patient study participation per patient request.
  • Collect, process, and ship blood, urine, and stool specimens during patient visits.
  • Complete and audit case report forms (CRFs) per FDA guidelines, ensuring alignment with medical records.
  • Submit patient stipends and reimbursement requests post-visit.
  • Maintain regulatory documentation and ensure proper filing.
  • Monitor and log specimen storage temperatures.
  • Order and distribute dry ice as needed.
  • Track expiration dates on clinical supplies and reorder as necessary.
  • Assist with preparation of source documents and study materials.
  • Support subject recruitment through chart reviews, outreach, and scheduling.
  • Process lab specimens and assist with vital signs collection.
  • Perform Fibroscans and phlebotomy once trained.
  • Provide general administrative support to ensure smooth departmental operations.
  • Perform other duties as assigned.

Minimum Qualifications

  • Bachelor’s degree (or four years of relevant clinical research experience in lieu of degree).
  • At least two years of experience in a healthcare-related role.
  • Prior experience conducting clinical trials required; pharmaceutical trial experience preferred.

Preferred Qualifications

  • Strong verbal and written communication skills; able to present information clearly to physicians, staff, and patients.
  • Proficiency in Microsoft Office; familiarity with EMR systems required.
  • Demonstrated ability to work collaboratively in a team environment.
  • Critical thinking and problem-solving skills.
  • High attention to detail and professional conduct.
  • Completion of Good Clinical Practice (GCP) and IATA training.
  • Flexibility to work variable hours as needed.
  • Phlebotomy experience preferred.
  • Self-motivated with a strong willingness to learn and take initiative.
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Clinical Research Coordinator

32792 Winter Park, Florida SQRL

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Job Description

Highlights

  • $33 - $38/hr based on experience
  • Great benefits including 401k w/match and 15 days PTO
  • Consistent schedule, no overnights or weekends
  • Work with Phase I - III cardiovascular and metabolic studies!

About Our Client

Our client is a fast growing site network that currently has over 35 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas: cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. Their sites conduct studies spanning Phases I-IV and they've been awarded for excellence in recruitment and recognized in the industry for retention, a best-in-class experience for patients and sponsors.


Responsibilities

As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!


  • Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans.
  • Patient recruitment, enrollment, scheduling, and consent
  • Lab procedures and shipments
  • Maintain GCP and follow protocols
  • Data management in EDC systems
  • Overall coordination of the study


Qualifications:

  • 2+ years of experience working as a CRC on sponsor backed clinical trials
  • Phlebotomy and lab processing experience (ability to perform without supervision)
  • Ability to work on site M-F on site (there is no remote or hybrid days)
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Clinical Research Coordinator

Missouri, Missouri Arch Clinical Trials

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Job Description

This position assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the sponsoring agency, monitoring and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.


Duties and Responsibilities:

•   Coordinates screening and enrollment of clinical trial patients to ensure proper execution of assigned complex clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met. 

•   Reviews physician-patient schedules and assesses patients for possible clinical trial enrollment.

•   Educates patients and families during the informed consent process.

•   Registers patients and participants to protocols.

•   Ensures eligibility requirements are met and reviewed with the physician investigator.

•   Ensures protocol-required patient testing is ordered and complete.

•   Maintains record of recruitment strategies.

•   Markets protocols as needed to meet recruitment goals.

•   Coordinates clinical trial activities and research done at the inpatient and outpatient units.

•   Gathers and verifies source documents

•   Verifies the accuracy, completeness and timely submission of case report forms.

•   Collaborates with the investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response.

•   Interview patients to assess adverse events, medication compliance, and patient-reported outcomes.

•   Obtains follow-up data required when the patient is off active treatment.

•   Corrects and resubmits data or answers queries within one week of receipt or as requested by the pharmaceutical company; reviews expectation reports; notifies research base of errors.

•   Maintains drug inventory

•   Maintains inventory of individual drug accountability records.

•   Ensures treatment order is correct by reviewing protocol guidelines and calculating the dose prescribed.

•   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.

•   Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate.

•   Respond to queries

•   Participates in review and development of SOPs, and internal procedures. 

•   Analyzes and develops action plans to address findings, including development of CAPA reports

•   Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements

•   Performs CRC, Reviewer and Unit staff duties if required

•   Maintains adequate, accurate, complete and legible records

•   Detailed review of subject and study documentation, CRFs and source documents

•   Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)

•   Performs other tasks as assigned and as training and experience allow. 

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Clinical Research Coordinator

New York, New York NYC Research Inc.

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Job Description


Position Summary: The Clinical Research Coordinator will be responsible for overseeing all aspects of the organization's clinical research program. This is role that requires a deep understanding of clinical trial methodologies, regulatory requirements, and a commitment to maintaining the highest standards of research integrity. The ideal candidate will possess excellent leadership, communication, and organizational skills.


Qualifications

Minimum Qualifications:

To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related field.

Minimum of two years of progressively responsible project coordination experience, preferably in a research setting.

Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power Point and Outlook.

Familiar with Internet applications.

Effective oral, written, communication, interpersonal skills.

Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers.

Ability to work within a team environment as well as independently.

Commitment to continuous learning as required by department administration.

Ability to operate research related equipment

Ability to work and make decisions independently.

Time management skills and ability to multitask.

Ability to identify, analyze and solve problems: Ability to work well under pressure.


Preferred Qualifications:

Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines).

Knowledge of basic medical terminology is preferred.

Responsibilities:

  1. In this role, the successful candidate is responsible for providing moderate to advanced range of coordination of Research studies conducted within the Division.
  2. Coordinator will assist with the recruitment, enrollment, grant submissions, research data collection and study coordination activities
  3. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and required obligations to patient/subject, Principal Investigator, Research Team and sponsor.
  4. Interfaces directly with patients/subjects and Principal Investigator in support of the clinical trials if applicable.
  5. Oversee the implementation of research protocols.
  6. Ensure research sites are well-prepared and equipped to conduct trials, including overseeing site initiation, monitoring, and close-out visits.
  7. Prioritize and monitor patient safety throughout all trials, ensuring adverse events are reported promptly and accurately.
  8. Develop and execute strategies to meet and exceed patient recruitment and enrollment targets.


Benefits

  • This position is a Full-Time position with competitive salary and benefits package being offered.
  • Room for development, growth, and upward mobility within the company.
  • Medical, Dental and Vision Insurance options to fit your lifestyle needs.
  • 401(k) Program.
  • Performance Incentives.
  • Base Salary Range: $40.00-$50.00, commensurate with experience
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