IFMA Foodverse

The Compliance Manager reports to the Associate Director, Regulatory Affairs and Compliance in the Office of Human Research Ethics and through the Director to the Vice Chancellor for Research. This position will be responsible for leading, planning, monitoring and facilitating a culture of compliance in human subject research conducted across all areas of campus, including the Schools of Medicine, Pharmacy, Public Health, Nursing, Dentistry and Academic Affairs. 
General responsibilities include:
* Reviews reportable events and makes determinations or initial assessments and recommendations regarding the event. Works with investigators and research teams to develop a Corrective Action Plan and manages the overall processing and documentation of the event.
* Initiates and responds to high level communications with federal regulatory agencies (OHRP, FDA) on behalf of the University. These actions would include reporting of investigator noncompliance, seeking federal interpretations in complex research scenarios. 
* Works with external sites and IRBs on compliance issues and communicating local determinations, facilitating audits, etc. 
* Coordinates audits by external agencies, including federal regulators. 
* Participates in ongoing work to maintain national accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This position must assimilate complex concepts and regulations, translate them into operational guidelines, revise the SOPs accordingly, and transmit this information to all affected parties. 
* Responsible for the oversight of one Compliance Analyst.

The Office of Human Research Ethics (OHRE) administers, supports, and oversees the work of the Institutional Review Boards (IRBs) and all related activities at UNC-Chapel Hill. Any research project involving human subjects proposed by a member of the faculty, a postdoc, a staff member, or a student at UNC-Chapel Hill must be reviewed and approved by an IRB before that research may begin and before related grants may be funded. These IRBs are federally mandated review committees, operating under regulations promulgated by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA). 

The IRBs and OHRE are critical components of UNC-Chapel Hills Human Research Protection Program (HRPP) that serves to protect the rights and welfare of more than one million human research subjects who take part in more than 6,000 different research projects each year at UNC-Chapel Hill. All components of the HRPP must work together to ensure institutional compliance with ethical principles and regulatory requirements.

Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.

Excellent organizational and written oral communication skills; and ability to work effectively with university researchers, faculty, and administrators. Must be able to exercise a high degree of independent judgment and discretion related to research compliance issues.

Preferred qualifications include demonstrated knowledge of federal and local policies that govern human subjects research, including Code of Federal Regulations and UNC-Chapel Hill Standard Operating Procedures, or clear demonstration of ability to learn and apply these regulations and policies. A national certification program has been developed (Certified IRB Professional, CIP) and it is expected that holders of this position would be eligible and encouraged to pursue certification.