Regulatory Assistant

Reports to:
Regulatory Specialist
Job Summary:

The primary responsibilities of the Regulatory Administrator is to assist with the regulatory and compliance associated with clinical trials.

Duties Include but are not limited to:
  • Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and
    guidelines related to consent, ethical conduct and protection of human subjects
  • Ensures compliance with all agencies
  • Maintains strict confidentiality according to HIPPA regulations
  • Assist Regulatory Specialist in obtaining continuing approvals
  • Assist Regulatory Specialist with sponsor and/ or CROs during monitoring visits
  • Ensure Monitor confirmation and follow-up letters are received for each visit
  • Maintain list of IRB expiration dates for all trials to ensure periodic reports are submitted on time
  • Archive completed trials
  • Maintain spread sheets of licenses and certifications, checking for approaching expiration dates and notifying appropriate staff members
  • Maintain and update CV’s
  • Assist Regulatory Specialist with their day-to-day activities, including but not limited to:
    • obtaining signatures on regulatory documents, filing study documents, processing
    • personnel changes, revising regulatory documents and maintaining study
    • binders/electronic folders
  • Attend and support study initiation visits
  • Assist with safety report management
  • Assist with ICF and study amendments to assure research has the correct documents
Knowledge, Skills, and Abilities
  • Ability to work independently with minimal supervision
  • Demonstrated excellent written, oral, communication, presentation, planning and interpersonal skills
  • Excellent communication skills and a high degree of professionalism with all types of people
  • Excellent organizational skills with a strong attention to detail
  • Well-developed organizational and analytical skills
  • Critical thinker and problem solver
  • Friendly, outgoing personality; maintain a positive attitude under pressure
  • Contribute to team goals
  • Proficiency in Microsoft Office Suite
  • A high level of self-motivation and energy with an optimistic, “can do” attitude
Education and Experience
  • Associates Degree preferred, however equivalent education and experience accepted Specialty Certification in Clinical Research preferred
  • Some Clinical Research experience a plus

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