Advanced Clinical Research Coordinator

Cincinnati Children's; United States; On-site; USD 57,000 - 81,000; Full time

Job summary

Cincinnati Children’s is seeking a Clinical Research Coordinator to join the Allergy department. The role involves study conduct, regulatory submissions, recruitment, communication, and data management to support multiple clinical trials.

You will work with investigators, monitor visits, ensure participant safety, maintain regulatory records, and train staff. A Bachelor’s degree (or higher) with related experience is required, with CRC Certification encouraged.

Responsibilities

• 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 by additional divisions, regulatory agencies, or consultants, & coordinate the process to meet these requirements. Apply legal, regulatory & policy parameters to promote ethical practices in research involving human participants & to ensure compliance to those regulations. Document the conduct of each protocol’s regulatory activities in appropriate s
• Recruitment/Enrollment/Retention - Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI and or management. Identify potentially eligible participants. Conduct pre-consent screening to determine eligibility. Review consent form with participant and provide time for participant to consider study participation. Execute the informed consent process according to GCP and CCHMC procedures and other applicable rules, regulations and policies. Communicate with participants’ clinical team regarding study participation. Document in applicable systems (tracking, electronic health, etc.) participants approached, screened and enrolled in the study. Communicate challenges with recruitment and retention to the study leadership. Make rec

Education

Bachelor’s degree with 1 year experience OR Master’s degree

CRC IV requirements: Bachelor with 3 years or Master with 2 years + CRC cert within 18 months

Job description

Cincinnati Children’s is seeking a Clinical Research Coordinator to join the Allergy department. The role involves study conduct, regulatory submissions, recruitment, communication, and data management to support multiple clinical trials.

You will work with investigators, monitor visits, ensure participant safety, maintain regulatory records, and train staff. A Bachelor’s degree (or higher) with related experience is required, with CRC Certification encouraged.