Clinical Research Coordinators (Non-R.N.)

Details

This clinical research coordinator position will involve assisting with a NIDA-funded UG3/UH3 trial of ketamine-assisted psychotherapy for patients with opioid use disorder on buprenorphine. The study compares an 8-week Mindfulness-Oriented Recovery Enhancement (MORE) + 2 ketamine sessions to an 8-week supportive therapy intervention + 2 ketamine sessions. In addition to clinical outcomes and experiential outcomes, we are tracking with this trial, we will be examining dyadic EEG synchrony between study participants and the study therapist to better understand how therapeutic alliance, connection, and engagement predict therapeutic outcomes in psychedelic-assisted therapies. This role will involve coordination of day-to-day clinical trial activities in accordance with Good Clinical Practices (GCPs), study protocols, and applicable regulations, implementation processes, and organization of efforts within the study team to achieve objectives, and coordination of research procedures, study visits, and follow-up care. This role will also involve maintaining tools and documentation to track study outcomes and providing updates to regulatory bodies and the study team, maintaining source documents, assessing and reporting adverse events (AEs), recruiting, screening, and obtaining consent from study participants, as well as interacting directly with study participants and their families / interpersonal supports. This role will work alongside another full-time clinical research coordinator and a team of study therapists, co-investigators, and the PI, Benjamin Lewis, MD.

Candidates should be highly skilled and proficient in clinical research coordination and be able to conduct complex, important work under minimal supervision with wide latitude for independent judgment. Preference will be given for prior experience working with individuals with substance use disorders or vulnerable populations.

1. Coordinate and manage day-to-day clinical trial operations in compliance with Good Clinical Practice guidelines, study protocols, institutional policies, and applicable local, state, and federal regulations.
2. Independently plan, organize, and implement complex study activities to meet protocol objectives, including scheduling and conducting study visits, procedures, and required follow-up.
3. Serve as an operational liaison along with another full-time coordinator for assigned studies, collaborating effectively with Principal Investigators, study sponsors, clinical teams, ancillary departments, external partners, and regulatory entities.
4. Lead participant recruitment, screening, enrollment, and informed consent processes, ensuring ethical conduct, protocol adherence, and subject safety.
5. Collect, review, and maintain accurate and complete source documentation, regulatory binders, and study records, ensuring audit and inspection readiness at all times.
6. Coordinate and support pre-study feasibility, site qualification, study initiation, monitoring, and close-out visits, including preparation of materials and timely resolution of action items.
7. Identify, document, and report adverse events, serious adverse events, and protocol deviations in accordance with regulatory requirements and sponsor timelines.
8. Oversee collection, entry, and quality control of participant, clinical, and laboratory data, resolving queries and discrepancies with minimal oversight.
9. Develop, maintain, and utilize tracking tools to monitor study milestones, enrollment progress, regulatory deadlines, and other key performance metrics, providing regular updates to investigators and management.
10. Apply advanced knowledge and independent judgment to troubleshoot complex study issues, escalate risks appropriately, and recommend process improvements.
11. Provide guidance, training, or informal mentorship to junior research staff, contributing to team effectiveness and consistent application of best practices.
12. Maintain participant-focused communication,