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CO37 – Regulatory Assistant

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.

    Email To:

    kimberly.rosenberg@fdhs.com

    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
    • Additional Duties/responsibilities may be assigned as needed

    Other 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

    Experience:

    • Associates Degree preferred, however equivalent education and experience accepted Specialty Certification in Clinical Research preferred
    • Some Clinical Research experience a plus