Oncology Research Regulatory Specialist II

CO2000 H. Lee Moffitt Cancer Center and Research Institute, Inc.; United States; On-site; USD 60,000 - 92,000; Full time

Job summary

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

The role focuses on regulatory document completion, submission, proper filing, informed consent creation, IRB/IBC applications, and serving as liaison with study teams and audits to maintain audit-ready files.

Qualifications

• High School Diploma/GED required.
• HSD with 4+ years of clinical research regulatory experience (preferably in oncology).
• Associates 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).
• Two (2) years experience in oncology.

Responsibilities

• Independently prioritize and evaluate regulatory requirements and submissions for each study.
• Identify the difference between compassionate use, emergent use, humanitarian device, biomedical, and social science studies to file the appropriate IRB application.
• Provide seamless coverage (Study Startup and/or Maintenance) to any disease programs, as requested by management.
• Create, maintain and update informed consent forms and IRB/IBC Applications.
• Review and extract all required data from the protocol, investigator's brochure, and any other pertinent source documentation to complete the application process to include drafting the informed consent by combining model consent language with Institutional and respective IRB's terminology.
• Mentoring and Training of new regulatory staff. Provides mentoring/training to new regulatory staff as well as other members of the research team(s). Act as central contact for regulatory queries, providing documentation and processing requests.
• Serves as the primary liaison for protocol regulatory support and will be in constant communication with internal and external customers; meets with study teams regularly to provide progress updates.
• Collaborates with Research Staff in responding to Internal/External Audits. Gather required documentation for internal/external audits collaborating with the research staff and draft regulatory responses.
• Regulatory Files Creation and Maintenance Assist in assuring that all study documents, including SOP's and regulatory files are maintained in audit-ready condition.

Skills

Regulatory knowledge

Attention to detail

Communication

Oncology experience

Education

High School Diploma/GED

Associate or Bachelor's Degree

Master's Degree

Job description

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

The role focuses on regulatory document completion, submission, proper filing, informed consent creation, IRB/IBC applications, and serving as liaison with study teams and audits to maintain audit-ready files.