Regulatory Specialist I

H. Lee Moffitt Cancer Center

Tampa, FL

Job posting number: #7107262 (Ref:hlj_38909)

Posted: August 4, 2022

Application Deadline: Open Until Filled

Job Description


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.

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


Mission To create a Moffitt culture of diversity, equity, and inclusion as we strive to contribute to the prevention and cure of cancer. Vision To advance and accelerate a culture of access, equity, and inclusion. Diversity is a priority at Moffitt and is meant "to promote a culture of diversity and inclusion as we contribute to the prevention and cure of cancer." The Enterprise Equity Department focuses its efforts on eliminating those obstacles to an individual’s ability to exist within their personal comfort zone at the cancer center. Everyone is important to meeting this priority. Addressing and responding to diversity and inclusion fosters an environment where mutual respect for diverse cultures, communication styles, languages, customs, beliefs, values, traditions, experiences and other ways in which we identify ourselves, is the expectation.


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More Info

Job posting number:#7107262 (Ref:hlj_38909)
Application Deadline:Open Until Filled
Employer Location:H. Lee Moffitt Cancer Center
Tampa,Florida
United States
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