Senior Clinical Research Coordinator

Job Description

Job Description

Position Summary

We are seeking a Senior Clinical Research Coordinator to lead the day-to-day execution of industry-sponsored drug trials in psychiatry and neurology. This role is suited to an experienced coordinator who has served as a lead coordinator on sponsor-initiated studies and is ready to take ownership of study startup through closeout, mentor junior staff, and serve as a primary point of contact for sponsors, CRAs, and the Principal Investigator.

· Serve as lead coordinator on industry-sponsored psychiatry and neurology drug trials, owning protocol execution from site initiation through closeout.

· Manage day-to-day study conduct, including participant screening, informed consent, visit scheduling, and protocol-directed assessments (e.g., rating scales, cognitive batteries, safety assessments).

· Serve as the primary site contact for sponsors, CRAs, and monitors; prepare for and support site initiation visits, monitoring visits, and audits.

· Maintain regulatory binders and source documentation in compliance with ICH-GCP, FDA regulations, and sponsor requirements.

· Coordinate with the Principal Investigator and sub-investigators on protocol adherence, adverse event reporting, and clinical decision-making.

· Oversee data entry and query resolution in EDC systems, ensuring timely and accurate data submission.

 

· Manage IP (investigational product) accountability, including receipt, storage, dispensing, and reconciliation per protocol.

· Support IRB/IEC submissions, continuing reviews, and protocol amendments.

· Train, mentor, and provide day-to-day guidance to junior clinical research coordinators.

· Identify and troubleshoot study-level issues (recruitment, protocol deviations, timeline risk) and escalate appropriately.

· Support participant recruitment and retention strategies specific to psychiatric and neurological patient populations.

· Master's degree required (life sciences, clinical research, nursing, psychology, or related field).

· Minimum of 2–3 years of experience coordinating industry-sponsored clinical trials specifically within psychiatry and/or neurology.

· Demonstrated experience serving as a lead coordinator on industry-sponsored drug trials, with direct sponsor and monitor interaction.

· Strong working knowledge of ICH-GCP guidelines and FDA regulations governing clinical research.

· Experience with informed consent processes, source documentation, and regulatory binder maintenance.

· Proficiency with EDC systems and clinical trial management systems (CTMS).

· Excellent organizational skills with the ability to manage multiple concurrent studies and competing deadlines.

· Strong written and verbal skills, with experience presenting to sponsors and auditors.

 

· 80,000-85000.00 based on experience

· Benefits summary — health insurance, PTO, retirement, professional development

· Growth path / advancement opportunities

 

\nCompany Description

Diverse team of researchers dedicated to advancement of research in mental health.