Clinical Research Coordinator II/III - Endocrinology

Cincinnati Children's; Cincinnati (OH); On-site; USD 52,000 - 75,000; Full time

Job summary

Cincinnati Children's is seeking a professional to support Study Conduct/Clinical Research Practice, ensuring compliance, coordinating facilities and supplies, and handling specimen collection, processing and storage per protocol.

Additionally, responsibilities include regulatory submissions, audit readiness, monitor visits, and collaboration with investigators to advance clinical studies in a compliant environment.

Qualifications

• Experience in clinical research procedures and regulatory documentation.
• Knowledge of SOPs and study conduct.

Responsibilities

• Maintain awareness of status of all active studies, arrange facilities and supplies, ensure participant and study compliance, collect, process and store specimens per protocol and SOPs, log and store specimens and maintain required records.
• Prepare, submit and maintain regulatory submissions, anticipate audits/inspections, participate in monitor visits and quality reviews, review human research protocols with authorities, determine additional requirements.

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