Regulatory Startup Project Coordinator

H. Lee Moffitt Cancer Center

Tampa, FL

Job posting number: #7089346 (Ref:hlj_33946)

Posted: November 17, 2021

Application Deadline: Open Until Filled

Job Description


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

Essential Job Functions: 

  • Responsible for shepherding clinical research projects through the study start up process and oversees the development of study regulatory documents
  • Primary liaison for regulatory protocol activation issues for internal and external customers; meets with team(s) regularly to provide progress update 
  • Work on quality metrics for the study activation processes 
  •  Work with Clinical Trials Office training staff to provide new and ongoing education to clinical research staff on Study Activation Procedures

 

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 /research knowledge and organizational skills
  • Oncology experience preferred (2 years)


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.


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