Central Study Coordinator I
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 ManagementGCPData management
Requirements
- At least 3 years of relevant clinical research experience.
- Bachelor’s degree preferred, or equivalent combination of education, training, and experience.
- Excellent working knowledge of government regulations, GCP, and ALCOA-C.
- Proficiency in clinical trial software including IWRS and EDC.
- Proficiency with Microsoft Office (Word, Outlook, Teams, Excel).
- Strong communication and customer service skills.
- Ability to work effectively in a remote environment.
- Proper home office set-up with private space and high-speed internet.
- CCRC certification preferred.
Responsibilities
- Perform the Informed Consent process with study participants virtually.
- Pre-screen and educate potential study participants on the study.
- Schedule, prepare for, and facilitate participant visits.
- Perform protocol mandated visit activities maintaining GCP compliance.
- Manage participant referral portals and study specific applications.
- Maintain all study documentation in accordance with ALCOA-C.
- Enter data and resolve queries in EDC and other portals.
- Identify, document, and report Adverse Events and Serious Adverse Events.
- Host regular calls with assigned PIs as the subject matter expert.
- Facilitate communication between study site, CRA, and sponsor.
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