Clinical Research Coordinator I

City/State: Bronx, New York Grant Funded: Yes Department: Neuro - Research/Clinical Work Work Shift: Day (MON-FRI), 8:30 AM-5 PM (8.5 hours daily) Role Overview Clinical Research Coordinator I – responsible for overseeing multiple clinical trials, investigator‑initiated studies, and quality improvement projects within the Neurology department. Acts as the primary point of contact for patients, families, and the clinical study team, coordinating across hospital departments to ensure seamless completion of trial activities. Responsibilities Direct the daily flow of trial‑related activities, including recruitment and clinical assessments of study subjects. Ensure strict adherence to study protocols and regulatory requirements (IRB, NIH, FDA). Design and implement workflow processes for clinical trials, providing reminders and updates to the clinical team. Coordinate team members to complete clinical and non‑clinical protocol tasks, assigning appropriate personnel for medical and administrative duties. Execute IRB submissions such as event reporting and study status changes. Manage patient billing across multiple databases, including the electronic medical record. Develop and execute action plans to keep all study tasks on schedule and implement corrective measures when necessary. Lead manuscript preparation, drafting abstracts, coordinating co‑author input, and preparing data for peer‑reviewed journals. Escalate trial conduct issues to the Principal Investigator (PI) and senior research staff. Assign training to the PI and research team for protocol amendments and required study training. Screen and consent patients, schedule and coordinate study visits as dictated by protocol. Collect data and imaging, ensuring accurate entry into EDCs/databases and image upload to portals. Develop multifaceted recruitment strategies, integrating creative outreach with workflow and cross‑department partnerships. Monitor data quality for sponsors and audit findings, escalating issues to site managers. Maintain accurate and confidential study participant records. Prepare essential documents for FDA, regulatory bodies, and sponsors, and maintain regulatory binders. Provide binders and documents to PI, sponsors, and regulatory authorities upon request. Coordinate monitoring visits and audits, ensuring compliance with sponsor and IRB requirements. Process, package, store, and ship clinical specimens as required. Manage device accountability, ordering, and storage of investigational products and lab kits. Perform other duties as assigned, depending on the clinical trial. Qualifications B.S. or equivalent degree required. Completion of annual OHS assessment required. Fit test for occupational health and safety required. CITI Good Clinical Practice Certification. CITI Research with Biomedical Drugs and Devices Certification. CITI Dangerous Goods and Biospecimen Handling Certification. Experience in clinical research, clinical trials, and/or related medical professions. Preferred Position primarily based at the Moses campus; occasional travel to other Montefiore locations as needed. Equal Employment Opportunity Montefiore Medical Center is an equal employment opportunity employer. We recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law. Automated Employment Decision Tools Notice (AEDT) #J-18808-Ljbffr