Job Description
Job Summary:
The Clinical Research Coordinator will work under the direction of the Principal Investigator to manage and execute clinical trials in accordance with Good Clinical Practice, FDA regulations, and study protocols. This position requires a detail-oriented professional with strong communication skills to ensure the safety of trial participants and the integrity of study data.
Key Responsibilities:
Oversee the day-to-day operations of assigned clinical trials from start-up to close-out. Ensure strict adherence to study protocols and all regulatory requirements, including those from the FDA and IRB. Accurately collect, record, and maintain source documents, case report forms, study data and assist with query resolution. Act as a liaison between the Principal Investigator, study participants, sponsors, and monitors. Maintain accurate accountability records and manage the inventory of study supplies and investigational products. Participate in monitoring visits, audits, and inspections.
Must have a strong knowledge of GCP, HIPAA, and FDA regulations, excellent communication skills, strong attention to detail, exceptional written and verbal communication and interpersonal skills and the ability to work independently and manage multiple priorities.
Full-time position with PTO, health insurance, dental insurance, vision insurance and holiday pay.CCRC certification preferred.
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