Summary

This position independently coordinates and manages clinical research studies within the Department of Psychiatry and Behavioral Sciences. The position supports research programs focused on human abuse potential studies, including H-56391- Evaluation of the safety and effects and psychoactive substances in people with past opioid use, and ensures compliance with study protocols, sponsor requirements, regulatory guidelines, and institutional policies.

Job Duties

• Study Coordination and Participant Management
  • Coordinate and manage clinical research studies from study start up through closeout.
  • Recruit, screen, consent, enroll, and retain research participants.
  • Schedule and conduct study visits and protocol required procedures, including the administration of visual analog scales, and coordination of blood collection procedures.
• Research Operations and Data Management
  • Collect, enter, verify, and maintain research data, source documentation, and study records.
  • Coordinate laboratory testing, specimen processing, shipment, and maintenance of laboratory records as required by study protocols.
  • Maintain study databases and ensure data quality and protocol compliance.
• Regulatory Compliance and Participant Safety
  • Prepare and maintain regulatory documents, including IRB submissions, amendments, continuing reviews, and study files.
  • Monitor participant safety and report adverse events and protocol deviations according to institutional and sponsor requirements.
• Study Team and Sponsor Coordination
  • Serve as the primary liaison between investigators, sponsors, study staff, and research participants.
  • Support monitoring visits, audits, sponsor communications, and other study-related activities.
  • Assist with grant reporting to the FDA, recruitment initiatives across VA and non-VA sites, and specimen shipping to collaborating institutions.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• One year of relevant experience.

Preferred Qualifications

• Specialized Procedures or Skills: cognitive assessments, like the CAPS-5 and MINI Psychiatric assessment, and biospecimen processing, including packaging and shipment of study specific specimens.