Job Description

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.
  
   

Work Authorization Requirement:

This position is not eligible for visa sponsorship.  Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment. 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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