The Regulatory unit is responsible for the management of study protocols and supporting documents submitted to regulatory bodies. The unit submits continuations, amendments, respond to questions, generates reports, and maintains files and documentation involving the regulatory requirements for all studies conducted at MU-JHU.
- Establish and maintain research files and documentation pertaining to regulatory requirements for clinical trials
- Participate in the pre-pending study management
- Process including Confidentiality Disclosure Agreements and Feasibility Questionnaires
- Meet with Monitors from pharmaceutical companies or the research sponsors during evaluation visits to assess study progress
- Work closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date
- Maintains research practices using Good Clinical Practice guidelines
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