Cancer Center Jobs

Regulatory Specialist I

Moffitt Cancer Center

January 17, 2019
The Protocol Review and Regulatory Affairs department is looking for a Regulatory Specialist I.  

Position Highlights:
  • 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.
Ideal Candidate:
  • 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.
Responsibilities:
  • 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
To submit an application, please visit www.moffitt.org/careers requisition #28564