Synapticure
Clinical Research Coordinator (CRC II)
Visa Source Listed
📍🇺🇸 United States📅8h agoRemote
gcp
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Job Description
About Synapticure:
As a patient and caregiver-founded company, Synapticure provides instant access to expert neurologists, cutting-edge treatments and trials, and wraparound care coordination and behavioral health support in all 50 states through a virtual care platform. Partnering with providers and health plans, including CMS' new GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases like Alzheimer’s, Parkinson’s, and ALS.
About the Role:
The Clinical Research Coordinator (CRC) plays a key role in supporting Synapticure’s remote and decentralized research programs, including Expanded Access Programs (EAPs) providing investigational treatment and longitudinal natural history studies for individuals living with ALS . This role is designed for a research professional with 2–3 years of clinical research coordination experience who can operate with a moderate level of independence while collaborating closely with investigators and research leadership.
The CRC II is responsible for independently managing day-to-day study activities, maintaining regulatory and study documentation, and serving as a primary point of contact for research participants and study partners. The position requires strong organizational skills, sound judgment, and the ability to prioritize tasks across multiple studies in a fast-paced, mission-driven environment.
The most successful candidates are compassionate, detail-oriented, and proactive, with experience navigating clinical research workflows and a commitment to patient-centered, compliant research conduct.
Job Duties – What You’ll Be Doing
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.
Originally posted on Himalayas