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
• Maintain accurate, timely documentation in compliance with ALCOA standards
• Communicate with sponsors, CROs, monitors/CRAs, IRBs, labs, and site personnel
• Support monitor visits and maintain study readiness
• Manage study inventory and order supplies as needed
• Travel to investigator meetings as required
• Promote teamwork, flexibility, and support tasks outside regular duties
• Occasional evenings, weekends, and overtime may be required
REQUIRED SKILLS AND EXPERIENCE
• 1+ year of clinical research experience
• Formal medical training, healthcare education, or hands‑on clinical experience
• Strong knowledge of medical terminology
• Ability to perform clinical and diagnostic procedures (vitals, labs, etc.)
• Experience with AE/SAE reporting and informed consent preferred
• Strong organizational, multitasking, and time‑management skills
• Excellent written, verbal, and interpersonal communication skills
• Proficient with office software and site documentation systems
• Ability to work independently in a fast‑paced research environment
• Ability to be ambulatory most of the day and lift/manipulate equipment as needed
Pay: $28-$32/hr