Clinical Research Coordinator II/III - Endocrinology

Cincinnati Children's Office of Academic Affairs and Career Development; Cincinnati (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Cincinnati Children's Office of Academic Affairs and Career Development is seeking personnel to ensure proper conduct of clinical studies, including specimen collection, processing and storage, while maintaining full regulatory compliance across active research projects.

The role involves training staff on study procedures, coordinating with investigators and sponsors, and supporting audit-readiness through proactive documentation and quality reviews.

Qualifications

• Maintain awareness of status of all active studies and ensure participant and study compliance.
• Define specimen collection, processing and storage procedures and train staff to execute them.

Responsibilities

• Prepare, submit and maintain regulatory submissions to all collaborative parties.
• Oversee monitoring visits, audits and quality reviews and ensure audit-readiness.

Job description

• Study Conduct/ Clinical Research Practice - Maintain awareness of status of all active studies. Arrange for facilities and supplies. Ensure participant and study compliance, i.e. collection of study specimens, and study visits. Work with study team as needed to define specimen collection, processing and storage procedures. Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set. Ensure specimens are properly logged, handled and stored. Maintain all records and files required by regulatory agencies and sponsors. Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial. Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies. Train new staff in preparation and conduct of clinical trials.


• Regulatory Compliance and Documentation - Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties. Periodically self-audit records to ensure audit-readiness. Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner. Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, e.g. the need for review