Regulatory Specialist II — Oncology Research Submissions

Moffitt Cancer Center; Tampa (FL); On-site; USD 60,000 - 92,000; Full time

Job summary

Moffitt Cancer Center in Tampa, FL seeks a Regulatory Research Specialist to support regulatory activities from activation through closure, ensuring compliance with internal policies, sponsors, state statutes, and federal regulations governing human subjects research.

The role emphasizes reviewing protocols, drafting informed consent, managing IRB/IBC submissions, biosafety reviews, and mentoring junior staff, with collaboration across study teams and audits.

Qualifications

• High School Diploma or GED required.
• 4+ years of clinical research regulatory experience (preferably in oncology).
• Associate's or Bachelor's Degree with 2 years of clinical research regulatory experience (preferably in oncology).
• Master's Degree with 1 year of clinical research regulatory experience (preferably in oncology).

Responsibilities

• Independently prioritizes and critically evaluates the regulatory requirements and submissions for each study.
• Identify differences between compassionate use, emergent use, humanitarian device, biomedical, and social science studies to file the appropriate IRB application.
• Provide seamless coverage to Study Startup and/or Maintenance for disease programs as requested by management.
• Create, maintain and update informed consent forms and IRB/IBC Applications.
• Review and extract required data from protocols and related documents to complete the application process, including drafting informed consent using model language with IRB terminology.
• Process applications for Biosafety Committee review in conjunction with IRB applications.
• Mentor and train new regulatory staff and other research team members.
• Act as central contact for regulatory queries and as primary liaison for protocol regulatory support.
• Collaborate with Research Staff in responding to audits and draft regulatory responses.
• Assist in maintaining audit-ready regulatory files and SOPs.

Education

High School Diploma/GED

Associate's Degree

Bachelor's Degree

Master's Degree

Job description

Moffitt Cancer Center in Tampa, FL seeks a Regulatory Research Specialist to support regulatory activities from activation through closure, ensuring compliance with internal policies, sponsors, state statutes, and federal regulations governing human subjects research.

The role emphasizes reviewing protocols, drafting informed consent, managing IRB/IBC submissions, biosafety reviews, and mentoring junior staff, with collaboration across study teams and audits.