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
