Job Description
Job Description
The Clinical Research Coordinator I supports and manages day‑to‑day activities for clinical research studies, ensuring strict compliance with FDA regulations, GCP guidelines, sponsor protocols, and IRB requirements. This role partners closely with investigators, sponsors, CROs, and participants to ensure accurate execution, documentation, and successful study completion.
Key Responsibilities
• Ensure compliance with FDA, GCP, IRB, sponsor, and protocol requirements
• Manage protocol deviations, informed consent, SAE and AE reporting
• Coordinate clinical trials from start‑up through close‑out
• Collect and document clinical data (vitals, EKGs, height, weight, etc.)
• Perform phlebotomy, specimen collection, processing, storage, and transport
• Obtain and review medical records as required
• Educate participants on study expectations, diaries, and medication restrictions
• Conduct patient phone visits per protocol requirements<...
The Clinical Research Coordinator I supports and manages day‑to‑day activities for clinical research studies, ensuring strict compliance with FDA regulations, GCP guidelines, sponsor protocols, and IRB requirements. This role partners closely with investigators, sponsors, CROs, and participants to ensure accurate execution, documentation, and successful study completion.
Key Responsibilities
• Ensure compliance with FDA, GCP, IRB, sponsor, and protocol requirements
• Manage protocol deviations, informed consent, SAE and AE reporting
• Coordinate clinical trials from start‑up through close‑out
• Collect and document clinical data (vitals, EKGs, height, weight, etc.)
• Perform phlebotomy, specimen collection, processing, storage, and transport
• Obtain and review medical records as required
• Educate participants on study expectations, diaries, and medication restrictions
• Conduct patient phone visits per protocol requirements<...