About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Summary</H2> </div><div><p>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.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Duties</H2> </div><div><ul> <li>Study Coordination and Participant Management <ul> <li>Coordinate and manage clinical research studies from study start up through closeout.</li> <li>Recruit, screen, consent, enroll, and retain research participants.</li> <li>Schedule and conduct study visits and protocol required procedures, including the administration of visual analog scales, and coordination of blood collection procedures.</li> </ul> </li> <li>Research Operations and Data Management <ul> <li>Collect, enter, verify, and maintain research data, source documentation, and study records.</li> <li>Coordinate laboratory testing, specimen processing, shipment, and maintenance of laboratory records as required by study protocols.</li> <li>Maintain study databases and ensure data quality and protocol compliance.</li> </ul> </li> <li>Regulatory Compliance and Participant Safety <ul> <li>Prepare and maintain regulatory documents, including IRB submissions, amendments, continuing reviews, and study files.</li> <li>Monitor participant safety and report adverse events and protocol deviations according to institutional and sponsor requirements.</li> </ul> </li> <li>Study Team and Sponsor Coordination <ul> <li>Serve as the primary liaison between investigators, sponsors, study staff, and research participants.</li> <li>Support monitoring visits, audits, sponsor communications, and other study-related activities.</li> <li>Assist with grant reporting to the FDA, recruitment initiatives across VA and non-VA sites, and specimen shipping to collaborating institutions.</li> </ul> </li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Minimum Qualifications</H2> </div><div><ul> <li>Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.</li> <li>One year of relevant experience.</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Preferred Qualifications</H2> </div><div><ul> <li>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.<br> </li> </ul></div></div></div><p> </p> <p> </p> <p> </p> <p><strong>Work Authorization Requirement:</strong></p> <p><strong>This position is not eligible for visa sponsorship.</strong> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment. </p> <p> </p> <p>Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p>