2,195 Health Sciences Researcher jobs in the United States

A Clinical Research Medical Director (CRMD) provides strategic medical leadership for clinical trials, developing protocols, overseeing data quality, ensuring regulatory compliance, and managing trial-related medical issues. They act as the internal medical expert for a disease, support the clinical development plan, and serve as a key liaison with internal teams and external stakeholders like regulators and key opinion leaders.

Key Responsibilities

• Clinical Strategy & Protocol Development:
• Lead the development of clinical trial strategies and protocols, ensuring they align with scientific principles, regulatory requirements, and business goals.
• Medical Oversight & Data Interpretation:
• Provide medical expertise to monitor and interpret accumulating clinical trial data, focusing on patient safety and efficacy, and may serve as a medical monitor for studies.
• Regulatory Compliance:
• Ensure adherence to regulatory requirements, such as Good Clinical Practice (GCP), and provide input for submissions and responses to regulatory authorities.
• Stakeholder Engagement:
• Act as a liaison with internal departments (e.g., Medical Affairs, Commercial) and external partners (e.g., investigators, key opinion leaders, patient advocacy groups).
• Team Leadership & Mentoring:
• Provide medical and scientific leadership to research teams, mentoring and developing staff to enhance their clinical research skills.
• Safety Management:
• Monitor trial integrity and safety, contribute to pharmacovigilance standards, and provide support for safety-related documents.

Qualifications

• Education:
• Typically requires an M.D. or D.O. degree, often with board certification or advanced training in a medical or scientific specialty.
• Experience:
• Significant clinical trial experience within the pharmaceutical industry or academia is required, along with experience in clinical development strategy and protocol design.
• Skills:
• Strong leadership, project management, and communication skills are essential for managing teams and interacting with diverse stakeholders.
• Knowledge:
• Deep understanding of clinical trial methodology, regulatory requirements, and therapeutic areas is crucial.

At Stanford University School of Medicine the work we do touches lives today and tomorrow. Through education, research , and healthcare, the School of Medicine improves health through leadership, diversity , collaborative discoveries, and innovation.

Whether working in departments with faculty , or in units that support the school , our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.

The department of Pediatrics at Stanford University is seeking a Clinical Research Coordinator Associate (CRC2) to conduct clinical research and work on complex projects / assignments . This interesting and unique opportunity will oversee the clinical research functions of a multi-site pediatric oncology consortium. Pediatric Oncology Experimental Therapeutics Consortium Research Development and Management Center (POETIC RDMC) is a phase I clinical trial consortium whose mission is "To promote early clinical development of promising therapies for children, adolescents , and young adults with cancer and related disorders". This position will oversee significant and key aspects of the consortium large research studies and work under close direction of the principal investigator and / or study supervisor.

Duties include:

• Serve as primary contact with research participants, sponsors , and regulatory agencies. Coordinate studies from startup through close-out.

• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.

• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents / case report forms.

• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.

• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents , and attend monitoring meetings with sponsors , acting as primary contact.

• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and / or management staff.

• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.

• Participate in monitor visits and regulatory audits.

* - Other duties may also be assigned

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $84,856.00 to 97,021.00 annually

DESIRED QUALIFICATIONS:

• Bachelor's degree in related medical field.

• Experience working with oncology clinical research studies.

• 1-2 years of experience in a clinical research setting is highly desirable .

EDUCATION & EXPERIENCE (REQUIRED):

Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.

• Proficiency with Microsoft Office.

• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

• Frequently stand , walk, twist, bend, stoop, squat and use fine light / fine grasping.

• Occasionally sit , reach above shoulders, perform desk based computer tasks , use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.

• Rarely kneel, crawl, climb ladders, grasp forcefully , sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law , the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

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.

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

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

Complexity of Work: Requires critical thinking skills, effective communications skills, decisive judgment and the ability to work with minimal supervision. Extensive knowledge of clinical trial operations, research methodologies, and regulatory compliance in clinical research. Must be able to work in a stressful environment and take appropriate action. Required Work Experience: Five (5) years of health care work experience and two (2) years' supervisory experience required. Clinical training as part of post secondary education preferred. Proven experience in leading and managing clinical research programs and teams in an academic, healthcare, or industry setting. Other Information: Additional Education Info: Master's degree in research, biology, chemistry, physical sciences, social sciences, public health, health sciences, math, statistics or related field of study. Education Equivalency: Bachelor's with, at least, seven (7) years of related experience in research, biology, chemistry, physical sciences, social sciences, public health, health sciences, math, statistics or related field of study.