Clinical Research Coordinator: Study Operations & Compliance

Cincinnati Children's Office of Academic Affairs and Career Development; Cincinnati (OH); On-site; USD 42,000 - 64,000; Full time

Job summary

Cincinnati Children’s is seeking a clinical research support professional to assist in coordinating studies, preparing regulatory documents, and ensuring IRB compliance. The role includes patient recruitment, data entry, and collaboration with the clinical team to advance translational pharmacology research.

The position emphasizes adherence to GCP/ICH, proper documentation, and maintaining study records across multiple systems, with routine collaboration across departments.

Qualifications

• High school diploma or equivalent.
• 2+ years of work experience in a related job discipline or equivalent.
• May require an Associate degree, vocational training, apprenticeships or equivalent.

Responsibilities

• Study Conduct/ Clinical Research Practice - Assist in coordinating studies, prepare protocols, informed consents, amendments and documents for IRB review.
• Regulatory Compliance and Documentation - Maintain records, SOPs, IRB correspondence, and regulatory binder per SOPs.
• Recruitment/Enrollment/Retention - Identify eligible participants, plan visits, and obtain informed consent per protocol.
• Communication - Organize correspondence, liaise with investigators, sponsors, and clinical teams.
• Data Management - Complete CRFs, ensure data accuracy, and support data-management processes.

Skills

Study coordination

Regulatory awareness

Data management

Participant recruitment

Documentation

Education

High school diploma or equivalent

Associate degree or equivalent

Job description

Cincinnati Children’s is seeking a clinical research support professional to assist in coordinating studies, preparing regulatory documents, and ensuring IRB compliance. The role includes patient recruitment, data entry, and collaboration with the clinical team to advance translational pharmacology research.

The position emphasizes adherence to GCP/ICH, proper documentation, and maintaining study records across multiple systems, with routine collaboration across departments.