Research Compliance Administrator II

Position Highlights

The Department of Psychiatry seeks a Research Compliance Administrator II to support various clinical trials involving several psychiatric indications. The Research Compliance Administrator II will work closely with the study staff and principal investigator to facilitate the clinical trials by screening participants, obtaining informed consent, recording interventions, obtaining labs and other required tests, completing case report forms, assisting with query resolution, and scheduling study participants for follow-up. The incumbent will work under limited or minimal supervision and will consult the principal investigator and management with highly unusual or complex situations.

Duties & Responsibilities

• Provides regulatory advice in the areas of research compliance and safety.
• Develop and/or advise on research compliance procedures, processes, and policies.
• Prepare, coordinate and maintain regulatory compliance and related documentation required by regulatory agencies or sponsors. Review and track regulatory documentation.
• Prepares and/or coordinates IRB submissions.
• Prepares and/or coordinates reports and updates for our funder(s).
• Works under limited or minimal supervision and consults Senior Professional with highly unusual or complex situations.
• Mentors and share knowledge with student workers and support staff.

Minimum Qualifications

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Minimum of 3 years of relevant work experience, or equivalent combination of education and work experience.

Preferred Qualifications

• Experience working in pharmaceutical clinical trials preferred.
• Experience working with behavioral, cognitive, and psychological testing.
• Experience compiling datasets for funder/sponsor reporting and updates, clinicaltrials.gov, and final project reporting.
• IRB experience preferred.