An official State of Ohio site. Here’s how you know
Live Chat
Contact
ODJFS Logo in OMJ Seeker Header

in
Clinical Research Coordinator II/III - DDBP - Esbensen Lab Job in Cincinnati, Ohio US

Clinical Research Coordinator II/III - DDBP - Esbensen Lab

Cincinnati Children's Hospital Medical Center - Cincinnati, OH

Posted: 12/2/2025 - Expires: 1/1/2026

Job ID: 292945394

Report this job
Apply Now
Print 

Job Description

We are seeking a dedicated Clinical Research Coordinator to support Dr. Anna Esbensen's study focused on children and teens with Down syndrome. This patient-facing role involves administering cognitive assessments and collaborating closely with a team of experienced CRCs-teamwork is essential. While familiarity with SharePoint, REDCap, and our internal regulatory system (HRS) is a plus, training will be provided. Experience working with individuals with intellectual or developmental disabilities and with children is preferred but not required. If you are passionate about research and making a difference in the lives of families, we'd love to hear from you!

JOB 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 systems. Maintain up-to-date & accurate written & electronic records & files to support clinical research activities. Continuously update knowledge of regulatory requirements. May act on behalf of the PI in communicating with sponsor, other divisions or institutions to coordinate studies & follow through on issues.

* 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 r

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjQzMjExLjEwNTA4QGNpbmNpbm5hdGljaGlsZHJlbnNjb21wLmFwbGl0cmFrLmNvbQ

Job Summary

Employment Type:
Full Time Employee
Job type:
Regular Employment
Skill Based Partner:
No
Education Level:
High school graduate
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
N/A
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 5
Graphic Literacy: 6

Workplace Documentation: 6