Reports to:

Job Summary:

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.