Regulatory Startup Project Lead for Clinical Trials

Moffitt Cancer Center; 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 meet activation timelines. You will lead regulatory specialists, develop start-up documents, and ensure timely completion of regulatory tasks across study teams.

Ideal candidates have a Bachelor's degree, 5 years in clinical research (2 in startup/regulatory roles), and knowledge of FDA regulatory requirements. Oncology experience is preferred.

Qualifications

• Bachelor's degree required; Master's degree preferred.
• Five years of clinical research experience, with at least 2 in study start-up or regulatory roles.
• 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 completion of regulatory tasks.
• Coordinate study activation meetings with disease-based study teams.
• Provide education to clinical research staff on Study Activation Procedures.
• Ensure systems/spreadsheets are updated with study information and dates.
• Create and review informed consent drafts in compliance with local requirements.

Education

Bachelor's degree (required)

Master's degree preferred

CCRP/CCRC certification

Regulatory knowledge

Oncology experience

Job description

Moffitt Cancer Center is seeking a Regulatory Startup Project Coordinator to shepherd clinical research projects through the study start-up process and meet activation timelines. You will lead regulatory specialists, develop start-up documents, and ensure timely completion of regulatory tasks across study teams.

Ideal candidates have a Bachelor's degree, 5 years in clinical research (2 in startup/regulatory roles), and knowledge of FDA regulatory requirements. Oncology experience is preferred.