Regulatory Specialist I
Job posting number: #7107263 (Ref:hlj_38910)
Posted: August 4, 2022
Application Deadline: Open Until Filled
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.
- 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.
Credentials and Qualifications:
- 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
Mission To create a Moffitt culture of diversity and inclusion as we strive to contribute to the prevention and cure of cancer. Vision Moffitt Cancer Center is recognized as the model wherein the diversity of our employees and communities is valued and supported as essential components to contributing to the prevention and cure of cancer. The cancer center is an equal opportunity employer. It is the policy of the cancer center to prohibit unlawful discrimination and harassment of any type and to afford equal employment opportunities to workforce members and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, disability, genetic information, veteran’s status or any other characteristic protected by federal, state or local law.