Regulatory & IRB Compliance Specialist

Moffitt Cancer Center; Tampa (FL); On-site; USD 33,000 - 50,000; Full time

Job summary

Moffitt Cancer Center in Tampa, FL is seeking a Regulatory Specialist I to support regulatory documentation for protocol activity from activation through closure. The role emphasizes accurate filing, regulatory compliance, and reporting to internal policies, IRBs, sponsors, and federal regulations.

Minimum qualifications include a High School Diploma or GED with 3+ years of relevant experience or an Associate's degree with 2+ years.

Qualifications

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

Responsibilities

• Assist in reviewing and extracting data from protocols and investigator’s brochures to complete IRB applications.
• Prepare draft informed consent documents using standard language and site terminology.
• Submit IRB applications and related addenda; reconcile IRB queries to secure study approval.
• File HIPAA/Consent waivers and organize regulatory documents in ebinders.
• Coordinate with study sponsors and internal teams for regulatory start-up activities.

Skills

Regulatory compliance

Documentation

Education

High School Diploma or GED

Associate's degree or higher

Tools

OnCore

eBinders

CTO tracking logs

Job description

Moffitt Cancer Center in Tampa, FL is seeking a Regulatory Specialist I to support regulatory documentation for protocol activity from activation through closure. The role emphasizes accurate filing, regulatory compliance, and reporting to internal policies, IRBs, sponsors, and federal regulations.

Minimum qualifications include a High School Diploma or GED with 3+ years of relevant experience or an Associate's degree with 2+ years.