Clinical Research Coordinator

Responsibilities

• Coordinate and execute clinical trial activities, including screening, enrollment, and participant follow-up visits
• Conduct pre-screening and assist with eligibility assessments using medical records and study criteria
• Facilitate and document the informed consent process per IRB and protocol requirements
• Schedule and manage study visits, ensuring protocol timelines and procedures are followed
• Maintain accurate source documentation, case report forms, and data entry in EDC systems
• Track and maintain study logs (e.g., screening/enrollment logs, prescreening logs, delegation logs, training logs)
• Maintain regulatory binders and ensure documents are current, compliant, and audit-ready
• Coordinate study procedures with internal departments (e.g., pharmacy, lab, imaging, and clinical staff)
• Support investigational product management, including coordination of ordering, dispensing, and accountability documentation
• Communicate protocol requirements (e.g., dosing, visit schedules, procedures) to relevant teams to ensure alignment
• Collaborate with investigators, sponsors, CRAs, and internal teams to support study progress
• Prepare for and support monitoring visits, including document organization and follow-up on action items
• Respond to sponsor and CRA queries and assist with data clarification requests
• Anticipate, manage, and escalate issues as appropriate
• Ensure compliance with ICH-GCP, FDA regulations, and institutional SOPs
• Support audit and inspection readiness through organized and consistent documentation practices
• Support study-related logistics, including budget-related tracking support and study supply coordination
• Participate in active recruitment, screening, and enrollment of potential study candidates, including discussing study protocols with potential study candidates and obtaining informed consent
• Collect, process, store, and ship biological specimens in accordance with protocol requirements, ensuring proper handling and documentation

Qualifications

• Strong attention to detail and organizational skills, with the ability to multitask, prioritize deadlines, and work independently while supporting participants and the investigative team
• Demonstrated ability to develop and implement processes in a growing or evolving clinical research environment preferred
• Working knowledge with electronic health record systems and familiarity with medical terminology
• Strong written and verbal communication skills, including the ability to produce high-quality technical documents and deliver effective written and oral presentations
• Demonstrates strong ethics and professionalism
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint), clinical trial databases (e.g., EDC and IRT systems), and various sponsor-provided platforms and vendors
• Experience Three (3) years of progressive experience in grant administration, research coordination, data collection, and/or facilitating the patient experience in research projects is required