Employment Type: Permanent Staff (EHRA NF)

Vacancy ID: NF0008065

Position Summary/Description:

The Director of Regulatory Affairs is responsible for planning, implementation and oversight of ethics and regulatory operations for the Institute for Global Health and Infectious Diseases ( IGHID ) investigators conducting observational and clinical research protocols. The Director supervises the activities of approximately 10 regulatory support staff members. The mission for the Regulatory Affairs group is to protect all study participants and assist researchers in their ethical and regulatory needs to further science and the mission of IGHID .

The Director of Regulatory Affairs is responsible for assuring that investigators and protocols comply with International ( ICH , Helsinki), Federal ( FDA , OHRP , NIH ), local requirements and sponsor requirements for the conduct of clinical research.

The research portfolio at the Institute currently includes projects in multiple countries including the United States, flagship sites in Malawi, Zambia, DRC , China, Vietnam and Liberia, as well as supported sites South Africa, Cameroon, Uganda, and Tanzania. Research protocols include studies on infectious diseases such as HIV , COVID , influenza, malaria, syphilis, tuberculosis, hepatitis B, ebola, lassa fever, zika, sapovirus and norovirus, and associated program evaluations and epidemiological studies. IGHID investigators also conduct international projects in the following disciplines: OB/Gyn, Oncology, Surgery and Psychiatry.

The Director provides oversight of IGHID regulatory personnel managing IRB applications in the US and globally. They work in a coordinating role with multiple domestic and international local and central IRBs. They are responsible for regulatory oversight and coordination of multicenter studies and network trials where UNC is the lead coordinating center.

The Director is responsible for regulatory management of information from multiple global sites and for development and oversight of tracking and storage systems, as well as preparation and presentation of reports to share with IRBs, investigators, and their research teams. The Director helps assess training needs at global sites and maintains regular communication with principal investigators, study teams, and regulatory authorities at these sites. They should have an awareness and appreciation for research in international settings and the contextual differences between cultures and practices. The Directors supports PIs with IRB reporting and provides guidance for navigating regulatory uncertainties and quandaries with the overseeing IRBs. The Director actively participates in regulatory submissions to the UNC Chapel Hill IRB and is responsible for developing a strong working relationship with IRB leadership.

Education and Experience:

Minimum of 5 years experience in clinical trials management that may include regulatory affairs, clinical trials coordination or clinical trials data management. Experience working on observational and clinical trials in an international setting(s) in preferred. Experience with a variety of IRB submissions including: use of a single IRB , reliance agreements, mutli-site studies, investigator initiated trials, E- IND / EAP , Unanticipated Problems, and FDA inspection preparedness of all regulatory files. The ability to attend virtual meetings during non-traditional work hours is a component of the position. The ability to periodically travel to international research sites for training and quality assurance reviews is preferred. Experience working with Part 11 compliant document systems preferred.

AA/EEO Statement:

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.