Summary

The Department of Psychiatry is seeking a full-time research professional to support Primary Investigators (PIs) in the execution of clinical research studies. The selected candidate will work closely with PIs to support study operations, including data collection, data management, and assistance with data analysis. Responsibilities also include generating accurate analytical results and preparing findings in clear, well-organized written formats.

This role requires the ability to work 100% on-site and flexibility to occasionally work early mornings or weekends based on patient visits.

Job Duties

• Independently manage 3–5 reliance psychiatric clinical trials (depression, anxiety, tardive dyskinesia, Alzheimer’s disease, bipolar disorder, substance use disorders, and schizophrenia) as primary or backup study coordinator from start-up through close-out.
• Oversee patient enrollment, including recruitment, pre-screening, chart review, and informed consent.
• Serve as primary liaison between the Principal Investigator and study participants; educate participants on study protocols, risks/benefits, procedures, and expectations.
• Create source documents and collect medical, psychiatric, and medication histories.
• Administer cognitive batteries including MCCB, BACS, DSST, SCoRS, VRFCAT, WRAT-4, and ToL.
• Conduct psychiatric structured interviews including MINI, SCID, PANSS, HAM-D, MADRS, BPRS, C-SSRS, HAM-A, TLFB, PWC-20, ATRQ, CIWA-Ar, SDS, YMRS, MOAA-S, CADSS, MMSE, and CGI-I/S.
• Perform movement disorder scales including AIMS, BARS, and SAS.
• Collect vital signs, perform EKGs and venipuncture, and process and ship biological specimens.
• Monitor participant safety; document adverse events, serious adverse events, and protocol deviations in accordance with regulatory guidelines.
• Maintain participant retention through consistent communication and follow-up.
• Ensure accurate and timely data entry and query resolution.
• Register trial participants and research related visits in CTMS and generate invoices.
• Prepare for and participate in audits, site qualification, site initiation, monitoring, and closeout visits.
• Complete feasibility questionnaires and study start-up packets for new clinical trials.
• Coordinate with sponsors and CRO to facilitate protocol activities and maintain current study documentation.
• Maintain Investigator Site File for protocol amendments, investigators brochure, FDA Form 1572, delegation logs, training logs, and study manuals.
• Submit investigator applications to central IRBs. Prepare initial submissions, amendments, and renewals in Brain and e-Protocol systems.
• Perform additional research-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Master’s degree or higher required (MD strongly preferred).
• Background in psychology, social work, or a related clinical field.
• Experience with assessments, particularly psychiatric or cognitive testing.
• Research experience preferred, especially in clinical or pharmaceutical studies.
• Exposure to patient-facing clinical environments.
• Familiarity with Epic is a plus.