Remote Regulatory Specialist II - Oncology Trials

Moffitt

Tampa (FL)

Remote

USD 60,000 - 92,000

Full time

10 days ago

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Job summary

Moffitt Cancer Center in Tampa, FL invites a Regulatory Specialist II to support human subjects research regulatory activities from activation to closure. You will ensure compliant document completion, filing, and reporting in line with internal policies and sponsor requirements.

The role emphasizes IRB/IBC submissions, informed consent management, audits readiness, and coordination with study teams. Remote eligibility allows flexible work arrangements while maintaining site collaboration.

Qualifications

  • Requires solid understanding of regulatory submissions for human subjects research.
  • Experience with IRB, IBC, and biosafety processes preferred.
  • Oncology regulatory knowledge is highly desirable.

Responsibilities

  • Prioritize and evaluate regulatory requirements for each study.
  • Prepare and update informed consent forms and protocol documents.
  • Draft and file IRB/IBC applications and biosafety requests.
  • Coordinate study startup and maintenance regulatory activities.
  • Mentor and train junior regulatory staff.
  • Serve as liaison for regulatory questions with internal/external teams.

Skills

Clinical regulatory experience
IRB/IBC submissions
Oncology experience

Education

High School Diploma or GED
Associate's or Bachelor's degree in a relevant field
Master's degree in a related field

Job description

Moffitt Cancer Center in Tampa, FL invites a Regulatory Specialist II to support human subjects research regulatory activities from activation to closure. You will ensure compliant document completion, filing, and reporting in line with internal policies and sponsor requirements.

The role emphasizes IRB/IBC submissions, informed consent management, audits readiness, and coordination with study teams. Remote eligibility allows flexible work arrangements while maintaining site collaboration.

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