Manager - Research Compliance

The Manager of Research Compliance will play a key role in assuring compliance with federal regulations related to the protection of human subjects in research, the use of biological agents, toxins and recombinant/synthetic DNA, management and reporting of research misconduct, research conflicts of interest, and conduct of research training.

Bachelor's degree required; Master's degree in biomedical or healthcare related field and Certified IRB Professional (CIP) preferred.

Knowledge of and experience with regulatory requirements for research compliance. Familiarity with HIPAA regulations and regulations governing human subjects in research. Demonstrated knowledge and understanding of the IRB process and protocol development and approval. Working knowledge of scientific and medical concepts and terminology, and strong familiarity with biomedical research protocols. Working knowledge of research terminology. Supervisory and personnel management experience. Experience with developing and delivering outreach programs on federal regulations and University policy for research compliance committees, faculty, researchers, staff and students. Demonstrated ability to work collaboratively to successfully develop, implement and monitor programs and processes. Advanced general office equipment and computer skills, including MS Office. An understanding of research requirements, especially those related to research misconduct, responsible conduct of research and research conflicts of interest. Experience conducting research investigations and knowledge of clinical research billing compliance reviews and auditing. In depth knowledge of human and non-human subject research compliance and private laws and regulations. Strong knowledge of OHRP and FDA regulations governing federal research grants. Experience with IRB database, specifically IRB+ program a plus.

A minimum of 5 years of leadership experience working in a research environment in an Academic Medical Center, higher education or related field.

Preferred: One or more years in an IRB position. Experience working in a Human Research Protection Program (HRPP). Experience in a regulatory or research compliance environment