What are the responsibilities and job description for the REGULATORY SPECIALIST II position at Moffitt Cancer Center Careers?
At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America’s Best Large Employers and America’s Best Employers for Women, Computerworld magazine’s list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time’s Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet® designation in recognition of its nursing excellence.
Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999.
Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.
Summary
Position Highlights:
- Support research activities through the critical evaluation and completion of protocol specific documents and standardized reports for effective and compliant protocol activity from activation through closure.
- Focus on regulatory document completion, submission, proper filing and reporting to achieve and maintain compliance with internal policy, external sponsors and federal regulations pertinent to research involving human subjects.
Responsibilities:
- Extract all required data from protocols, investigators brochure, and any other pertinent source documentation to complete the application process, including drafting the informed consents.
- Reconcile all IRB queries to ensure study approval.
- Gather required documentation for internal/external audits collaborating with the research staff and draft regulatory responses.
- Independently process Biosafety applications and complete OBA requirements as necessary.
- Electronically file all correspondence for future retrieval and upload all IRB approvals to e-binders and CTMS accordingly.
Credentials and Qualifications:
- High School diploma with 4 (four) years of clinical regulatory experience required OR Associate’s/Bachelor’s degree with 2 (two) years of clinical research regulatory experience OR Master’s Degree with 1 (one) year of regulatory experience.
- CCRA, CCRC, CCRP, CIP or CIM certification preferred.
- Previous experience in a medically related field or an understanding of medical terminology required
