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

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times’ Top Workplaces. Summary Position Highlights: To support research regulatory activities through the critical evaluation and completion of protocol specific documents and standardized reports for effective and compliant protocol activity from activation through closure. The primary focus is on regulatory document completion, submission, proper filing and reporting to achieve and maintain compliance with internal policies, external sponsor, state statutes, and federal regulations pertinent to research involving human subjects.

Responsibilities

• Independently prioritizes and critically evaluates the specific regulatory requirements and submissions for each study in assigned program(s).
• Identify the difference between compassionate use, emergent use, humanitarian device, biomedical, and social science studies to file the appropriate IRB application.
• Ability to 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.
• Independently process applications for Biosafety Committee review in conjunction with IRB applications.
• 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.

Credentials and Qualifications

• High School Diploma/GED required.
• HSD with 4 or more 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).
• Preferred: Two (2) years experience in clinical research regulatory experience, including study activation.
• Two (2) years experience in oncology.

Salary Range $60,424.00 - $92,102.40 Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions. We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.

Moffitt Career Site If you have the vision, passion, and dedication to contribute to our mission, then we have a place for you!

Equal Employment Opportunity

Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.

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