Clinical Research Coordinator I (CRC-1)

Core Competencies

• Foundational knowledge of clinical trial operations, Good Clinical Practice (GCP), FDA regulations, and IRB processes
• Strong organizational skills with attention to detail and the ability to manage multiple priorities under supervision
• Effective communication and interpersonal skills with study participants, team members, and external stakeholders
• Commitment to participant safety, data integrity, and regulatory compliance
• Eagerness to learn, adapt, and grow within a fast-paced clinical research environment
• Proficiency in electronic health record (EHR) systems; exposure to electronic data capture (EDC) and clinical trial management systems (CTMS) preferred

Key Responsibilities

• Study Coordination
• Coordinate assigned clinical trial activities under the direction of the CRC III – Team Lead/Site Director/Site Manager and the Principal Investigator
• Cover site preparation, study startup, participant screening, enrollment, and follow-up visits
• Ensure protocol adherence, timely data entry, and accurate source documentation for assigned studies
• Prepare for and support monitoring visits, audits, and sponsor interactions
• Participant Interaction and Recruitment
• Serve as a point of contact for study participants, providing education about the study and addressing questions
• Obtain and document informed consent in compliance with ICH-GCP and IRB requirements
• Conduct prescreening activities and coordinate with the Patient Recruitment department to support enrollment goals
• Participate in community engagement and outreach activities as directed
• Data Collection and Management
• Collect, record, and maintain accurate clinical trial data, ensuring integrity and confidentiality of participant information
• Enter data into EDC systems accurately and within sponsor-required timelines
• Manage query resolution and data clarification as directed by the CRC III – Team Lead or sponsor monitors
• Regulatory and Quality Support
• Support preparation and submission of IRB documents, amendments, and safety reports
• Support the maintenance of essential regulatory files and study documentation
• Participate in internal quality assurance activities and assist with CAPA implementation as directed
• Maintain compliance with GCP, institutional policies, and applicable regulatory requirements

Qualifications

• Strong understanding of or willingness to learn clinical trial processes and the regulatory environment
• Minimum 1 year experience supporting clinical research study coordination at the site level
• Excellent organizational skills and attention to detail, with the ability to manage multiple priorities and deadlines
• Strong interpersonal and communication skills, with the ability to build rapport with participants and collaborate effectively with team members
• Proficiency in electronic health record (EHR) systems; familiarity with EDC and CTMS platforms preferred
• Phlebotomy skills preferred
• Ability to work both independently and collaboratively in a fast-paced environment