[Remote] IRB Compliance Monitoring Specialist (Office of Human Subjects Research)

Note: The job is a remote job and is open to candidates in USA. Inside Higher Ed is seeking an IRB Compliance Monitoring Specialist to oversee compliance monitoring for IRB approved studies. The role involves conducting monitoring reviews, ensuring adherence to FDA regulations, and providing support and recommendations to enhance compliance within the research community. Responsibilities • Schedule and conduct, monitoring reviews for IRB approved studies • Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to • Review the available FDA required documentation for completeness and accuracy • Familiarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trial • Discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records • Review regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trial • During the review, prepare a written report of findings and observations • Discuss with principal investigators and study team members the regulatory and participant review findings, to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices • Provide support and resources based on regulatory requirements and best practices • Finalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review Board • Participate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance compliance • Conduct customized research compliance in-service training sessions at the request of JHM departments or divisions • Serve as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulations • Provide practical recommendations to implement strategies to increase regulatory and subject compliance • Ability to establish priorities, work independently, and proceed with objectives in a fast-paced, online environment • Other duties as assigned Skills • Bachelor's Degree • Three years of related clinical/medical research experience • Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula Company Overview • Inside Higher Ed is the online source for news, opinion, and jobs related to higher education. It was founded in 2004, and is headquartered in Washington, District of Columbia, USA, with a workforce of 51-200 employees. Its website is https://www.insidehighered.com/. Apply tot his job Apply To this Job