Clinical Research Coordinator: Study Operations & Compliance

Cincinnati Children's; Cincinnati (OH); On-site; USD 42,000 - 65,000; Full time

Job summary

Cincinnati Children’s is seeking a collaborative professional to support Study Conduct/Clinical Research Practice. The role involves coordinating studies, preparing protocols and informed consents for IRB review, assembling supplies, collecting and labeling samples, and maintaining equipment and inventory.

Additional responsibilities include regulatory documentation, audit readiness, participant recruitment and enrollment, communication with clinical teams, and data management to ensure accuracy

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 by preparing personnel and materials, preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor.
• Regulatory Compliance and Documentation: identify regulatory activities to be completed and assist in maintaining accurate records and regulatory binders.
• Recruitment/Enrollment/Retention: identify eligible participants, coordinate study visits, and support informed consent processes.
• Communication: organize correspondence, coordinate with investigators and study team members, and support study conduct improvements.
• Data Management: complete CRFs and source documentation, audit data, and support data-management processes.

Job description

Cincinnati Children’s is seeking a collaborative professional to support Study Conduct/Clinical Research Practice. The role involves coordinating studies, preparing protocols and informed consents for IRB review, assembling supplies, collecting and labeling samples, and maintaining equipment and inventory.

Additional responsibilities include regulatory documentation, audit readiness, participant recruitment and enrollment, communication with clinical teams, and data management to ensure accuracy