Clinical Trials Startup Project Lead

Moffitt Cancer Center; United States; On-site; USD 63,000 - 97,000; Full time

Job summary

Moffitt Cancer Center is seeking a Regulatory Startup Project Coordinator to shepherd clinical research projects through the study start-up process and ensure activation timelines meet institutional standards.

You will oversee regulatory start-up specialists, develop study documents, and lead problem-solving to keep studies on track while coordinating with study teams and training staff.

Qualifications

• Bachelor’s degree required (Master’s degree preferred).
• Five 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 FDA and other regulatory requirements.
• Oncology experience preferred (2 years).
• Strong scientific knowledge and research skills.

Responsibilities

• Oversee progress of study projects through the activation pathway.
• Development of study-related documents for start-up and activation.
• Continuous follow-up with internal and external customers during activation.
• Coordinate with disease-based study teams to schedule activation meetings.
• Provide education to clinical research staff on Study Activation Procedures.
• Ensure systems/spreadsheets are updated with study information.

Skills

Clinical research

Regulatory knowledge

Project coordination

Study activation coordination

Communication

Education

Bachelor’s degree

Master’s degree preferred

Job description

Moffitt Cancer Center is seeking a Regulatory Startup Project Coordinator to shepherd clinical research projects through the study start-up process and ensure activation timelines meet institutional standards.

You will oversee regulatory start-up specialists, develop study documents, and lead problem-solving to keep studies on track while coordinating with study teams and training staff.