The Protocol Review and Regulatory Affairs department is looking for a Regulatory Specialist I. H. Lee Moffitt Cancer and Research Institute is a modern facility in Tampa, Florida. We strive to be the leader in understanding in the complexity of cancer through team science and applying those insights for human benefits. Be part of the cure by joining Moffitt's team of over 800 research faculty scientists, career staff scientists, postdocs, graduate students and support staff dedicated to cancer research.
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.
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 ORAssociates degree with two (2) years of relevant experience required
BS/MS degree may substitute for relevant experience
H. Lee Moffitt Cancer Center has made a lasting commitment to the prevention and cure of cancer, working tirelessly in the areas of patient care, research and education to advance one step further in fighting this disease.