Clinical Research Coordinator III-1 (JR223682)

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Requisition #: JR223682

About the Role

The Clinical Research Coordinator III-1 at Cincinnati Children's Hospital Medical Center plays a critical role in supporting clinical research studies. This position involves coordinating and managing research protocols, ensuring compliance with regulatory requirements, and facilitating communication among study teams, sponsors, and participants.

Responsibilities

• Coordinate and manage clinical research studies, including protocol development, implementation, and close-out activities.
• Ensure compliance with federal, state, and institutional regulations, including IRB submissions and approvals.
• Recruit, screen, and enroll study participants; obtain informed consent and maintain accurate documentation.
• Schedule and conduct study visits, including collecting and processing biological specimens and study data.
• Monitor study progress, track participant visits, and maintain study records in accordance with Good Clinical Practice (GCP) guidelines.
• Collaborate with principal investigators, sponsors, and study teams to resolve issues and ensure study integrity.
• Prepare and submit regulatory documents, including adverse event reports and protocol amendments.
• Train and supervise junior research staff, students, or volunteers as needed.
• Assist with budget management, including tracking study expenses and reconciling accounts.
• Participate in study meetings, site visits, and audits as required.

Requirements

• Bachelor’s degree in a scientific, health-related, or social science field (e.g., nursing, biology, psychology, public health).
• Minimum of 3 years of experience in clinical research coordination or a related role.
• Knowledge of FDA, ICH-GCP, and HIPAA regulations governing clinical research.
• Experience with IRB submissions, regulatory documentation, and study monitoring.
• Strong organizational, communication, and problem-solving skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Proficiency with electronic data capture (EDC) systems, Microsoft Office, and research databases.

Preferred Qualifications

• Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP).
• Experience with pediatric or academic medical center research.
• Familiarity with Epic or other electronic health record (EHR) systems.
• Experience with REDCap, OnCore, or other clinical research management software.

Benefits

• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer matching.
• Paid time off (PTO) and holidays.
• Tuition reimbursement and professional development opportunities.
• Employee wellness programs and resources.
• Access to cutting-edge research and collaboration with leading experts in pediatric healthcare.