REGULATORY STARTUP PROJECT COORD at H. Lee Moffitt Cancer Center – Tampa, Florida

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

Summary:
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)