H. Lee Moffitt Cancer Center

Tampa, FL

Job posting number: #7236721 (Ref:hlj_53077)

Posted: April 17, 2024

Application Deadline: Open Until Filled

Job Description

The Protocol Review and Regulatory Affairs department is looking for a Regulatory Startup Project Coordinator.

The Regulatory Startup Project Coordinator is responsible for shepherding clinical research projects through the study start-up process to ensure activation time-lines meet (or exceed) institutional standards. This position will work with and oversee the activity of study start-up regulatory specialists. They provide leadership in developing study-related documents and problem-solving when issues that delay the study activation time-line are encountered.

Essential Job Functions: 

  • Oversee progress of study projects through the activation pathway at Moffitt Cancer Center.
  • Development of study-related documents that are needed for study start-up, so they are available when needed prior to activation.
  • Continuous follow-up with internal and external customers for the duration of the activation process to ensure the timely completion of regulatory-related tasks.
  • Work with disease-based study teams to schedule study activation meetings and processes to hand off responsibility of the studies.
  • Work with Clinical Trials Office training staff to provide new and ongoing education to clinical research staff on Study Activation Procedures.
  • Ensure appropriate systems/spreadsheets are updated accurately and compliantly with study information and study dates ensuring other study start-up regulatory specialists follow established process.
  • Create and review Informed Consents drafts in compliance with local requirements and protocol.

Credentials and Qualifications: 

  • Bachelor's degree required (Master's degree preferred)
  • Five (5) years' experience in clinical research (2 of the 5 years must be in a research study start up or regulatory position)
  • CCRP/CCRC or equivalent certification preferred
  • Working knowledge of Food and Drug Administration and other regulatory requirements
  • Strong scientific knowledge and research skills
  • Oncology experience preferred (2 years)

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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Job posting number:#7236721 (Ref:hlj_53077)
Application Deadline:Open Until Filled
Employer Location:H. Lee Moffitt Cancer Center
United States
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