HUMAN SUBJECTS RESEARCH ETHICS & EDUCATION MANAGER

Remote, USA Full-time
Provides leadership and vision for defining, developing, facilitating and tracking education efforts related to clinical research to support the enhanced understanding of and compliance with applicable regulations, guidance, and policies guiding clinical research, including OHRP regulations and guidance, FDA regulations and guidance, GCP guidance, state regulations, and institutional policies. Deliver education and training to support the ongoing needs of the research community, including physicians, leaders, IRB members, clinical research team members, VTCSOM students, and other employees. • Promotes and models the organizations Mission, Vision, and Values. • Directs the design, development and production of clinical research education, including print, web, audiovisual, digital and interactive materials. Oversees the distribution and delivery of content to physicians, leaders, IRB members, clinical research team members, VTCSOM students, and other employees. • Identifies needs of the clinical research community. Develops education strategies that take into account both biomedical FDA-regulated research and social-behavioral research, as well as Good Clinical Practice. • Conducts routine research education sessions and for-cause audits of clinical research studies due to requests from the IRB committee or Human Protections Administor or noncompliance. • Guide content of the Carilion Human Research Protection Program website and associated components in regards to research education content. • Develops and implements short- and long-term plans with measurable outcomes that support the strategic goals of clinical research education. • Coordinates activities with other departments and stakeholders. Works closely with colleagues in the development of materials and processes that improve clinical research education. • Ensures education is compliant with OHRP regulations and guidance, FDA regulations and guidance, GCP guidance, state regulations, and institutional policies. • Maintains professional affiliations as appropriate and participates in professional activities • Manages other projects as assigned. Apply tot his job
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