Clinical Research Coordinator II

Position Summary

The Clinical Research Coordinator III serves as the site-level leader for clinical research operations, ensuring successful study execution, patient recruitment, enrollment, retention, and data quality while maintaining compliance with protocol requirements, Good Clinical Practice (GCP), FDA regulations, and site standard operating procedures.

Key Responsibilities

• Review and understand assigned research protocols
• Assess site readiness and study resource requirements
• Train clinic staff on study objectives and eligibility criteria
• Implement workflows to optimize study recruitment and execution
• Cohort study activation activities with internal and external stakeholders
• Identify and pre-screen potential research participants
• Collaborate with providers and clinic staff to increase patient referrals
• Conduct informed consent discussions and documentation
• Partner with central research teams to meet enrollment goals
• Maintain strong patient engagement and retention throughout study participation
• Conduct protocol-required patient visits and assessments
• Perform vital signs, height, weight, ECGs, specimen collection, and other study procedures
• Administer questionnaires and study-related materials
• Dispense and collect investigational products
• Process laboratory specimens according to protocol requirements
• Maintain accurate source documentation and study records
• Complete timely and accurate data entry following ALCOA principles
• Maintain regulatory compliance with GCP, FDA, IRB, and sponsor requirements
• Report adverse events and serious adverse events within required timelines
• Prepare for sponsor and monitoring visits
• Maintain investigational product accountability and temperature logs
• Resolve data queries and monitoring findings promptly
• Coach and mentor Research Coordinators and site staff
• Aid in process improvement initiatives
• Support study planning, prioritization, and milestone management
• Foster a culture of quality, compliance, and patient safety

Qualifications

• Minimum 3-5 years of clinical research experience
• Strong understanding of GCP, FDA regulations, and clinical trial operations
• Experience managing multiple studies simultaneously
• Knowledge of medical terminology and research processes
• Experience with informed consent and patient recruitment
• Ability to perform: Vital signs, height and weight measurements, blood collection/phlebotomy, specimen processing, ECGs
• Excellent organizational, communication, and interpersonal skills
• Ability to work independently in a fast-paced environment