synapticure - Inc. - Clinical Research Coordinator (CRC II)

• Independently coordinates assigned study activities in accordance with study protocols, SOPs, and applicable regulatory requirements. • Screens potential research participants for eligibility, documents inclusion/exclusion determinations, and escalates complex eligibility questions as needed. • Manages scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities with minimal supervision. • Collects, reviews, and enters study data accurately and in a timely manner using electronic data capture (EDC) and other study systems. • Maintains complete and audit-ready study files, including regulatory binders, participant records, and tracking logs, in compliance with GCP and company standards. • Conducts or supports informed consent discussions, ensuring proper documentation, version control, and filing. • Serves as a primary point of contact for research participants and caregivers, addressing routine questions, coordinating logistics, and escalating clinical or protocol-related issues appropriately. • Prepares for and supports sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving queries or action items. • Tracks and reports study progress metrics such as enrollment, retention, deviations, and visit completion. • Identifies potential operational issues and proactively communicates risks, barriers, or improvement opportunities to research leadership. • Collaborates closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality, patient-centered research experience. • Supports onboarding and informal mentoring of junior research staff as appropriate. • ## Requirements – What We Look for in You • Bachelor’s degree in a scientific, health-related, or behavioral field preferred. • 2–3 years of experience as a Clinical Research Coordinator or equivalent role, preferably in interventional studies, decentralized trials, or neurology-related research. Experience in research with human subjects required. • Working knowledge of Good Clinical Practice (GCP), informed consent requirements, and clinical research regulations. • Demonstrated ability to manage study tasks independently while knowing when to escalate issues. • Strong organizational skills with the ability to prioritize across multiple studies and deadlines. • Excellent written and verbal communication skills, including comfort working directly with patients and caregivers. • Experience using electronic health records, EDC systems, CTMS, and study tracking tools. • Comfort working in a fully remote or virtual research environment using tools such as Zoom and secure messaging platforms. • Collaborative, adaptable, and dependable, with a proactive approach to problem-solving. • Alignment with Synapticure’s mission to expand access to high-quality research and care for individuals living with neurodegenerative disease.