Institute for Medical Research at the Durham VA Health Care System

Human Research Protection and Compliance Program Manager

The Human Research Protection and Compliance Program Manager plays a critical role in ensuring compliance with all applicable federal, state, and local regulations related to research activities conducted within the Durham VA Medical Center. This position will support the oversight of all research compliance programs, including but not limited to human subject research protections, data privacy, and research integrity. The role requires collaboration with researchers, administrators, and federal partners to foster a culture of ethical and compliant research within a complex, multi-faceted healthcare environment.

Location:

Candidates must reside within commuting distance of Durham, NC, or be willing to relocate before their start date.

This position is primarily in-office at the Institute for Medical Research and Durham VA Medical Center in Durham, North Carolina.  May be eligible for limited remote work based on organizational needs. Employee must reside in North Carolina by start and duration of employment. This role may require occasional travel.

Duties and Responsibilities:

 Regulatory Compliance Oversight (30%)

• Ensure that all research activities comply with applicable regulations, including Department of Veterans Affairs (VA) policies, federal and state laws, and institutional policies.
• Ensure all reportable incidents are communicated to the appropriate oversight office in a timely manner, including adverse events, protocol deviations, non-compliance, and privacy/security incidents.
• Work within IMR research teams and with VA Regulatory Compliance Officers in maintaining a compliant research program.
• Ensure appropriate oversight mechanisms are in place to maintain compliance with the determinations of the research committees.
• Act as liaison between R&D Committee and Investigators.
• Conduct regular audits and provide monthly reports about research compliance risks and corrective actions.

Training, Advisory, and Outreach (30%)

• Develop and implement a dynamic and comprehensive human subject research protection education program.
• Assess individual learner competency and tailor educational program to learner and team needs.
• Conduct group and individual sessions on broad and specific topics, driven by individual and team needs.
• Advise investigators and other research staff on local procedures, protocol development, and regulatory requirements.
• Disseminate policy changes to the local research enterprise in a timely manner using a variety of methods.
• Provide research training related to research activities regarding national regulatory rules and regulations as well as local policies and standard operating procedures to individuals with ancillary research responsibilities. (e.g. Privacy Office, R&D Committee, etc.)
• Collaborate with university affiliate personnel to provide joint education activities.

Human Research Subject Safety (25%)

• Develop local VA policies and procedures related to the protection of human subjects participating in medical, social, and behavioral research to ensure Researchers, Research Staff, IMR and the Medical Center adhere to all regulatory and compliance requirements.
• Maintain administrative policies and procedures and provides oversight for all aspects of protocol submissions, reviews, approvals, and renewal processes as well as post-approval administrative oversight and audits.
• Develop new procedures that will support effective management of protocol review processes, and develop procedures and systems for establishing, operating and assessing the effectiveness of Human Research Protection Program operations to meet local and established goals and objectives.
• Analyze program data to ensure compliance with human subject protection, compliance and reporting requirements, human subject and good clinical practice training requirements, accreditation, committee membership requirements, and Federal Wide Assurance (FWA) compliance.

Administrative and Regulatory (15%)

• Maintain the facility Federal Wide Assurance for both the Durham VA Medical Center and the IMR and ensures IRB registration remains current.
• Ensure compliance with IMR and Durham VA and Research Service’s continuing and mandatory education requirements and other continuing education needs.
• Work closely with the ACOS/R&D, R&D Committee, IRB Chairpersons, RCO, and AO for planning and execution of administrative and management functions related to the IRB and R&D Committee.
• Contribute to VA Research Administration meetings with a focus on quality improvement for all aspects of the program and develops improvement plans to support administrative needs, including research functions related to affiliate campuses.
• Perform other duties as assigned.

Required Skills and Experience:

• Bachelor’s degree in a relevant field (e.g., life sciences, public health, healthcare administration). Master’s degree or terminal degree is preferred.
• 4+ years of experience in research compliance, regulatory affairs, or related field, ideally within a VA Medical Center, healthcare system, or academic research institution.
• Strong understanding of VA research policies, federal research regulations (e.g., 45 CFR 46, 21 CFR 50), and ethical standards in human and animal research.
• Certification in research compliance (e.g., Certified IRB Professional, Certified Research Administrator) is a plus.
• Excellent communication skills, with the ability to effectively collaborate across departments and institutions.
• Strong analytical skills and attention to detail, with the ability to navigate complex regulatory environments.

Physical Requirements: The physical requirements and activities that are required to perform the essential functions of the position included, but may not be limited to, as follows: Must be able to occasionally lift, pull and push a minimum of 20 lbs., stand for extended periods of time, sit for extended periods of time, squat, kneel, stoop, regularly use fingers and hands for computer work.

Supervisory Controls: The position is under the direct supervision of the Executive Director/CEO of the Institute for Medical Research, with additional supervision by the ACOS-Research for VA-related tasks.

Salary Range: $80,000 - $110,000

Employee Benefits: IMR offers a competitive benefits package which includes health insurance, a matching 403(b) retirement savings plan, and paid holiday, vacation, and sick leave. Please visit https://imr.org/benefits/ for information about employee benefits.

IMR employees working on research are required to obtain a Without Compensation (WOC) appointment at the Durham VA Health Care System (DVACHCS). As a result, the successful candidate must undergo a federal background check and may be subject to a drug test and physical. Expected start date is typically 8-12 weeks following a job offer and is contingent upon completion and processing of VA paperwork. Participation in vaccination programs may be required for all Department of Veterans Affairs Health Care Without Compensation (WOC) appointments. We will not sponsor applicants for work visas.

Equal Opportunity Employer, including disabled persons and Veterans.