Regulatory Start-Up Specialist

Moffitt Cancer Center; United States; On-site; USD 33,000 - 50,000; Full time

Job summary

Moffitt Cancer Center in Florida is seeking a Regulatory Specialist I to support human subjects research by preparing protocol documents and regulatory reports from activation to closure.

The role focuses on IRB submissions, consent drafting, HIPAA compliance, and sponsor communication. You will work with research teams, maintain OnCore and eBinders records, and ensure CTO tracking while upholding internal policies and federal regulations.

Qualifications

• High School Diploma/GED required.
• HSD with 3 or more years of relevant experience or Associate's degree with 2 or more years of relevant experience.
• BS or MS degree may substitute the relevant experience.
• Thorough knowledge of word processing and database usage required.

Responsibilities

• Review protocol data to complete IRB applications.
• Draft informed consent combining model language with IRB terminology.
• Submit IRB documents and addenda.
• Process 1572 and financial disclosures.
• Coordinate with study teams and sponsors for required information.
• File HIPAA/Consent waivers when applicable.

Skills

Regulatory submissions

IRB/HRPP coordination

Data extraction

Informed consent drafting

HIPAA compliance

OnCore reports

Education

High School Diploma or GED

Associate's degree

BS/MS may substitute the relevant experience

Tools

OnCore

eBinders

Excel

Microsoft Word

IRB submission systems

Job description

Moffitt Cancer Center in Florida is seeking a Regulatory Specialist I to support human subjects research by preparing protocol documents and regulatory reports from activation to closure.

The role focuses on IRB submissions, consent drafting, HIPAA compliance, and sponsor communication. You will work with research teams, maintain OnCore and eBinders records, and ensure CTO tracking while upholding internal policies and federal regulations.