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Key Responsibilities:
- Independently prepare IRB documents, maintain regulatory files, and facilitate oversight of safety reporting.
- In concert with IND Sponsors, prepare and review IND submissions and communicate with the FDA.
- Lead study start-up and maintenance, submitting all required regulatory documents to open and close studies.
Regulatory Compliance:
- Establish and maintain processes to ensure regulatory documentation complies with IRB policies and federal regulations.
- Perform internal audit and quality assurance checks on regulatory documents and direct the clinical team for protocol compliance.
- Submit all regulatory documents to governing bodies to maintain study compliance with GCP and regulations.
Collaboration and Leadership:
- Serve as the lead contact for assigned trials, maintaining records and corresponding with all involved parties.
- Participate in developing standard operating procedures and mentor newly hired regulatory staff.
- Attend research team meetings to report on regulatory updates and issues, and handle administrative duties for budgets and contracts.
Emory University
Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.