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REGULATORY EDUCATION MANAGER, School of Medicine, Clinical Research
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Full-time
- The Clinical Research Resources Office (CRRO) is an office under the Human Research Protection Program (HRPP), which is a shared program of Boston Medical Center and BU Medical Campus.
- The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important aspects of the HRPP: the Research Professionals Network (RPN) and the human/clinical research education and training for Boston University and Boston Medical Center researchers (PIs and study staff).
- Education includes group educational offerings as well as individual, study-specific consultations on IRB application submissions, protocol planning, and study implementation.
- Develop, maintain and continually improve ongoing educational offerings of the Clinical Research Resources Office (CRRO), including PI training, coordinator trainings, and workshops on informed consent and AE monitoring.
- Provide consultations in the form of direct, one-on-one and small group education on regulatory aspects to the conduct of research throughout the life of the study, including: investigator and sponsor responsibilities, study conduct, adverse event reporting, documentation, consenting, protocol planning, IRB submissions, questions on study implementation, assistance with FDA IND/IDE submissions, consent development and writing, HIPAA issues, DSMP development, planning and submitting?
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