Central Study Coordinator I
New
C
Care AccessClinical Research
Remote within the United StatesFull-TimeMiddle
Salary75,000 - 95,000 USD per year
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Job Details
- Experience
- At least 3 years of relevant clinical research experience
- Required Skills
- Project ManagementGCPMicrosoft Office
Requirements
- At least 3 years of relevant clinical research experience.
- Strong working knowledge of government regulations, GCP, and ALCOA-C.
- Proficiency with Microsoft Office applications (Word, Outlook, Teams, and Excel).
- Experience navigating clinical research technologies such as EDC, IWRS, and recruitment platforms.
- Strong communication and customer service abilities.
- Proficiency in clinical research and medical terminology.
- Ability to work in a fast-paced environment and juggle multiple complex protocols.
- Strong organization, time management, and critical thinking skills.
- Private home office space for participant communication and high-speed internet (min. 100MB up/15MB down, 5 GHz router).
- Bachelor’s degree preferred, or equivalent combination of education, training, and experience.
- CCRC certification is preferred.
Responsibilities
- Perform the Informed Consent process with study participants virtually using e-consent technology.
- Pre-screen and educate potential study participants on study protocols and disease states.
- Manage participant referral portals and study-specific applications in compliance with GCP.
- Schedule and facilitate participant visits, coordinating logistics across MRI centers, infusion centers, and central raters.
- Maintain all study documentation according to ALCOA-C standards.
- Enter data and resolve queries in EDC systems within specified time windows.
- Identify, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Manage study work for assigned sites, including hosting regular PI calls and preparing meeting agendas.
- Facilitate communication between study sites, CRAs, and sponsors.
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