Regulatory Startup Lead – Clinical Trials Activation

SPEROS; Tampa (FL); Hybrid; 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 specialists, develop essential study documents, and ensure timely completion of activation tasks, while collaborating with disease teams and training staff on activation procedures.

Qualifications

• Bachelor's degree required.
• Five (5) years' experience in clinical research (2 of the 5 years in 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).

Responsibilities

• Oversee progress of study projects through the activation pathway.
• Develop study‑related documents needed for study start‑up and activation.
• Follow up with internal and external customers to ensure timely regulatory tasks.
• Coordinate study activation meetings with disease‑based study teams.
• Provide education to clinical research staff on Study Activation Procedures.
• Update systems/spreadsheets with study information and dates.
• Create and review Informed Consents drafts compliant with local requirements.

Skills

Regulatory coordination

Clinical research

Project management

Documentation

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 specialists, develop essential study documents, and ensure timely completion of activation tasks, while collaborating with disease teams and training staff on activation procedures.