Clinical Research Coordinator (CRC II)
In all 50 states through a virtual care platformFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 2–3 years
- Required Skills
- GCPEHR
Requirements
- 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.
- 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.
Responsibilities
- 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.
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