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CAREER OPPORTUNITIES

Regulatory Assistant

POSITION:
Regulatory Assistant


LOCATION
Manatee County


CATEGORY:
Clinical

Reports to:

Lead Regulatory Coordinator, Site Director

Job Summary:

The primary responsibilities of the Regulatory Assistant are assisting with the performance of clinical investigation projects in a clinical setting under the direction of the Lead Regulatory Coordinator.

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 Coordinator in obtaining continuing approvals
  • Assist Regulatory Coordinator with sponsor and/ or CROs during monitoring visits.
  • Ensuring Monitor confirmation and follow-up letters are received for each visit
  • Maintaining list of IRB expiration dates for all trials to ensure periodic reports are submitted on time
  • Boxing and storage of closed studies
  • Maintaining spread sheets of licenses and certifications, checking for approaching expiration dates and notifying appropriate staff members
  • Assist Regulatory Coordinator 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.
  • Schedule study initiation visits
  • Assist with safety report management
  • Assist with ICF and study amendments and assure research team is aware and has the correct documents
  • Ensure study team has their Study portal accesses
  • Additional Duties/responsibilities may be assigned as needed

Other Skills and Abilities:

  • Ability to work independently with minimal supervision.
  • 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.
  • Proficiency in Microsoft Office Suite

Experience:

  • Associates Degree preferred, however equivalent education and experience accepted. Specialty Certification in Clinical Research preferred.
  • Requires some clinical research experience.
  • Strong knowledge of IRB requirements and Federal and State regulations as they relate to research.

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