The Protocol Review and Regulatory Affairs department is looking for a Regulatory Specialist I.
- Gather required documentation for internal/external audits collaborating with the research staff and drafting regulatory responses.
- Coordinates protocols from initial start-up throughout closure.
- Files and maintains IRB/SRC determinations accurately.
- Serves as departmental liaison for Principle Investigators, Clinical Trials Coordinators. Data Specialists, Clinical Trials Office Managers, Regulatory Manager, Sponsors.
- Commitment to providing outstanding customer service
- Engaged, organized individual with strong critical thinking skills who has the ability to work efficiently under pressure.
- Highly motivated, shows initiative, is proactive and able to work independently as well as in a team.
- Demonstrates willingness to adapt to changing individual and institutional roles, needs and environment.
Credentials and Qualifications:
- Provide draft consents to sponsors for approval.
- Collaborate with research team/sponsor for scientific/clinical information required for application completion.
- Will file HIPPA/Consent waivers through the IRB when applicable.
- Reconcile all IRB queries to ensure study protocol.
- Will extract data to process IRB applications appropriately.
- Minimum high school diploma with three (3) years of relevant experience required OR Associates degree with two (2) years of relevant experience required
- BS/MS degree may substitute for relevant experience
- CCRC/CCRP or equivalent certifications preferred
To submit an application, please visit www.moffitt.org/careers