Clinical Research Study Coordinator

Job Requirements

Job Summary

A Clinical Research Study Coordinator works under the general direction of the Clinical Research Director and in collaboration with Research Managers, Research Nurses, Principal Investigators, and other research staff to assist with the coordination and implementation of multiple research studies. This role performs delegated day-to-day study activities related to compliance, regulatory requirements, recruitment, study initiation, monitoring, and close-out throughout the course of clinical research trials. The coordinator follows study protocols, institutional policies, and regulatory requirements to ensure the accuracy, integrity, and quality of study procedures and data collection activities conducted across research studies.

Primary Responsibilities

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job responsibilities performed.
• Coordinates and manages day-to-day activities for multiple clinical research studies in accordance with study protocols, institutional policies, and regulatory requirements.
• Assists with study start-up activities including regulatory submissions, site initiation preparation, and study documentation maintenance.
• Screens, recruits, consents, and schedules study participants while ensuring compliance with protocol-specific eligibility requirements.
• Maintains accurate and timely research documentation, source documents, case report forms, and study databases.
• Collaborates with Principal Investigators, Research Nurses, Research Managers, and other research staff to ensure efficient study conduct and communication.
• Prepares for sponsor, CRO, IRB, and regulatory monitoring visits, audits, and close-out activities, and address follow-up items as needed.
• Tracks study timelines, participant visits, investigational products, and protocol-required procedures to ensure adherence to study milestones and deadlines.
• Ensures compliance with Good Clinical Practice (GCP), institutional policies, HIPAA, and all applicable federal, state, and sponsor regulations governing clinical research activities.
• Perform all other related duties as assigned.

Work Experience

Education & Experience - Required
• High School Diploma or GED.
• Associate's degree in health sciences or related field. Combination of relevant education and experience may be considered in lieu of degree.
• Experience in clinical research support.

Education & Experience - Preferred
• Certification as a Clinical Research Associate through ACRP or SOCRA is preferred.
• 1-2 years of experience as a Research Coordinator or in clinical research support preferred.
• Working knowledge of medical terminology.

Knowledge, Skills, & Abilities
• Working knowledge of research regulatory and compliance
• Advanced Microsoft Office skills, including Access and PowerPoint
• Proven ability to use independent judgment and function autonomously
• Knowledge of clinical research processes, including patient screening, informed consent, protocol implementation, and study documentation management.
• Ability to communicate effectively and build rapport with patients, families, physicians, and interdisciplinary research teams in a professional and empathetic manner.
• Strong organizational and time management skills with the ability to coordinate multiple studies, prioritize competing responsibilities, and meet project deadlines.
• Working knowledge of Good Clinical Practice (GCP), HIPAA, IRB processes, and applicable regulatory requirements governing clinical research activities.
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, Outlook, and database management systems.
• Strong analytical and critical thinking skills with the ability to review medical records, interpret study requirements, and maintain accurate research data.
• Ability to work independently while exercising sound judgment and maintaining a high level of professionalism and confidentiality.
• Experience collaborating with physicians, research nurses, and research staff to support protocol execution, chart review, recruitment, and study coordination activities.
• Strong written communication and research skills, including literature review, data analysis, manuscript support, and preparation of study-related materials and reports.
• Ability to adapt in fast-paced clinical and research environments while maintaining attention to detail, accuracy, and patient-centered service.