Clinical Research Coordinator 3, Center for Neuromodulation Research

About the role

The Center for Neuromodulation Research (CNR) in the Department of Psychiatry and Neurobehavioral Sciences seeks an experienced Clinical Research Coordinator to lead day-to-day operations across a portfolio of clinical trials investigating non-invasive neuromodulation, including focused ultrasound (FUS) and vagus nerve stimulation (VNS), as treatments for substance use disorders and behavioral addictions. The Coordinator is the operational hub of the study team. They independently manage participant recruitment, screening, enrollment, and retention; ensure protocol fidelity and regulatory compliance; oversee data integrity across study databases; and serve as the primary point of contact for participants, community partners, and monitors. The role carries supervisory responsibility for junior research staff, interns, student volunteers, and peer recovery support staff and includes regular off-site work at community addiction treatment centers gathering data. This position suits someone who is scientifically curious, exceptionally organized, and genuinely comfortable working with individuals living with substance use and psychiatric disorders. Our participants are frequently navigating stigma, unstable circumstances, and complex care needs; the Coordinator sets the tone for how they experience research participation.

Responsibilities

• Screen and identify eligible participants against protocol inclusion and exclusion criteria; maintain accurate screening and enrollment logs.
• Obtain and document informed consent in accordance with IRB-approved procedures, ensuring participants understand study procedures, risks, and their right to withdraw.
• Conduct off-site recruitment and study visits at partnering addiction treatment centers and community organizations, working directly with service users and clinical staff.
• Develop and maintain recruitment strategies and relationships with referral sources; track and report recruitment metrics to the study team.
• Perform vital signs, pregnancy testing, and other urine-based testing (e.g., toxicology screening) per protocol.
• Collect, process, store, and ship study specimens in accordance with protocol, laboratory manuals, and applicable shipping regulations.
• Administer study questionnaires, behavioral tasks, and clinical assessments as trained and delegated.
• Recognize, document, and escalate adverse events and protocol deviations promptly and appropriately.
• Manage ongoing study organization activities, including scheduling study and MRI visits, coordinating research visit logistics across sites and imaging facilities, maintaining accurate study data, and assisting with the processing of participant study payments.
• Read, interpret, and follow clinical trial protocols exactly as written; serve as a protocol resource for junior staff.
• Prepare and maintain study documentation, including study visit schedules, study drug/device diaries, monitoring and training logs, delegation of authority logs, equipment records, and study correspondence.
• Support IRB submissions, amendments, continuing reviews, and reportable event submissions.
• Prepare for and participate in monitoring visits, audits, and sponsor communications; respond to queries and implement corrective actions.
• Collect and enter study data in a timely, accurate, and complete manner, maintaining corresponding source documentation.
• Build, maintain, and quality-check study databases (REDCap or equivalent); design data collection instruments and support data infrastructure for new protocols.
• Run routine data quality checks and reconcile discrepancies.
• Train Clinical Research Assistants, research interns, student volunteers, and peer recovery support staff; delegate tasks appropriately and monitor performance.
• Contribute to onboarding and training materials, SOPs, and study start-up activities for new protocols.
• Conduct literature reviews and contribute to manuscripts, abstracts, grant applications, and conference presentations as opportunities arise.
• Demonstrate a clear understanding of the centrality of participant safety in clinical research, and identify the specific components of a clinical trial protocol that exist to protect participants.
• Uphold Good Clinical Practice (GCP), Human Subjects Protection, HIPAA, and all applicable federal, state, and University regulations.

Minimum Requirements

• Education: Bachelor's Degree Required or equivalent combination of experience, education and/or certifications.
• Experience: Minimum of 3 years of clinical research experience required.
• Master’s degree may substitute for 1 year of clinical research experience.
• Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Preferred Qualifications

• Degree in a health, life sciences, psychology, neuroscience, or related field.
• Demonstrated ability to work effectively, non-judgmentally, and with genuine warmth with psychiatric and substance-using patient populations.
• Highly personable, with excellent interpersonal and communication skills; able to build rapport quickly and sustain participant engagement over time.
• Working knowledge of Good Clinical Practice (GCP) and human subjects protection principles; ability to complete CITI and GCP certification prior to study activities.
• Demonstrated ability to read, interpret, and adhere strictly to a written clinical trial protocol.
• Strong organizational skills and meticulous attention to detail; able to manage multiple studies and competing deadlines with minimal supervision.
• Comfortable performing vital signs and urine-based testing (training provided as needed).
• Experience with REDCap — including instrument design, project setup, and data infrastructure — or comparable electronic data capture systems.
• Prior experience with substance use disorder, addiction treatment, or psychiatric research populations, including in community or harm-reduction settings.
• Experience with IRB submissions, amendments, and regulatory binder maintenance.
• Familiarity with neuromodulation (FUS, VNS, TMS) and/or neuroimaging (MRI/fMRI) research protocols.
• Experience conducting literature reviews and contributing to scientific writing (manuscripts, abstracts, grant applications).
• Familiarity with statistical or data software (R, SPSS, MATLAB, Python).

Physical demands

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings and programs.