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Senior Clinical Research Coordinator

Chris Baily

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 elevate 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 Company Description Diverse team of researchers dedicated to advancement of research in mental health. Company Description Diverse team of researchers dedicated to advancement of research in mental health. #J-18808-Ljbffr Chris Baily

Vacancy posted 4 days ago
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