ID: 7057828 (Ref.No. 310744JC)
Posted: June 14, 2019
Application Deadline: Open Until Filled
Provides analytical and regulatory support to the clinical research support unit.
- Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submission strategies, and follow-up of submissions under review.
- Coordinates the planning, preparation, data collection, assembly, review and publication of regulatory submissions to the FDA and other government agencies.
- Reports and responds to agencies inquiries or comments.
- Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.
- Prepares regulatory reports and coordinate data collection and reporting with other departments. Tracks changes in regulatory guidelines as they may occur.
- Prepares updates on laws, regulations and guidelines for distribution to appropriate study personnel and investigators.
- Maintains working knowledge of regulatory changes through guidelines, articles, writings and courses.
- Supports Principal Investigators and study staff by assisting in the data collection and notification required for reporting of Adverse Events.
- Facilitates communication with IRB related to Adverse Events. Supports study monitoring, as needed and requested.
- Assists with regulatory affairs training.
- Bachelor's degree in a related field.
- Experience and working knowledge of federal regulations related to clinical trial research and IRB procedures.
- Master's degree in a related field.
- Regulatory Affairs Certification (RAC)