Lead Clinical Research Coordinator - 252341

Responsibilities

• •Study Coordination & Execution
• •Coordinate day-to-day activities of CNS clinical trials from startup through closeout
• •Assist with feasibility assessments and site readiness for neurological/psychiatric studies
• •Schedule and conduct study visits, including screening, baseline, treatment, and follow-up visits
• •Perform informed consent discussions and ensure proper patient comprehension
• •Collect, process, and ship biological samples (blood, CSF, saliva, genetic samples) according to protocol
• •Neurological & Cognitive Assessments
• •Administer or support standardized cognitive and functional assessments commonly used in CNS trials, including:
• •MMSE, MoCA
• •Coordinate with raters or serve as a trained rater (if certified), ensuring assessment consistency and quality
• •Data Management & Documentation
• •Maintain accurate and timely source documentation in compliance with ALCOA+ standards
• •Enter and query data in EDC systems (Medidata Rave, Veeva, etc.)
• •Ensure protocol deviations, adverse events, and concomitant medications are documented accurately
• •Maintain regulatory binders and essential documents
• •Support recruitment strategies tailored to CNS populations
• •Conduct prescreening to evaluate participant eligibility
• •Build rapport with patients and caregivers to support retention in long-duration CNS studies
• •15 more items(s)