Cincinnati Children's · 7 hours ago
Clinical Research Coordinator II -- Neurology
Cincinnati Children's is a leading children's hospital recognized for excellence in healthcare and research. The Clinical Research Coordinator II will assist in coordinating clinical studies, ensure regulatory compliance, and manage participant recruitment and data management activities.
Health Care
Responsibilities
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
Assemble lab kits and/or gather supplies
Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set
Ensure specimens are properly logged, handled and stored
Follow direction of clinical research coordinator or others involved in the clinical research project work
Assist other staff members and coordinators to implement studies
Maintain inventory of supplies and equipment
Operate standard laboratory and research study equipment, if applicable
Troubleshoot and correct erroneous results or problems with equipment
Identify regulatory activities to be completed and takes the initiative to complete
Coordinate and participate in the assembly of materials
Assist in maintaining up-to-date and accurate written and electronic records and files to support clinical research activities
Assist with audit readiness records review and preparation activities
Assist with maintaining protocol specific SOP's, IRB and regulatory correspondence
Demonstrate an awareness of federal regulations; state and local law; GCP/ICH and CCHMC policies to promote ethical practices in research involving human participants and to ensure compliance to those regulations
Recognize the importance of reporting concerns of ethical and/or regulatory issues to supervisor in a timely manner
Assist with the documentation of regulatory activities and maintenance of the regulatory binder in keeping with the institution and division SOPs
Seek out research educational opportunities
Maintain awareness of status of all active studies
Identify potentially eligible participants
Coordinate, plan and execute study visits and provide instructions and reimbursement to participants
Approach potential participants and families in a professional manner
Conduct pre-consent screening procedures according to protocol specifications to determine eligibility
Review consent form with participant and provide time for participant to consider study participation
Execute the informed consent process according to Good Clinical Practices (GCP), CCHMC procedures and other applicable policies
Communicate with participants' clinical team regarding study participation as indicated by protocol and/or manual of operations
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
Provide recommendations to improve recruitment and retention to the study leadership
Assist with organizing and filing all correspondence
Refer questions and issues that arise during study conduct to the appropriate research team member
Maintain awareness of study related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions
Maintain relationship with participants
Develop a rapport with study participants
Provide input to division discussions related to clinical research studies
Participate in meetings, discussions and activities designed to improve organizational performance through recommending areas or approaches for improving study conduct
Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines for human research
Review CRFs to ensure completeness, accuracy and compliance with Good Clinical Practice
Enter data into various auditable databases or electronic data-capture systems
Maintain internal record keeping system(s) in conjunction with study team members
Ensure accuracy of documentation from sources
Perform quality checks to ensure accuracy of data
Review reports, tables, and listings
Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors
Qualification
Required
High school diploma or equivalent
2+ years of work experience in a related job discipline or equivalent combination of education and experience
May require an Associate degree, vocational training, apprenticeships or equivalent
Company
Cincinnati Children's
Cincinnati Children’s, a nonprofit academic medical center established in 1883, offers services from well-child care to treatment for the most rare and complex conditions.
H1B Sponsorship
Cincinnati Children's has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (95)
2024 (110)
2023 (131)
2022 (124)
2021 (98)
2020 (68)
Funding
Current Stage
Late StageTotal Funding
$15.6MKey Investors
National Institutes of HealthFarmer Family FoundationLeducq Foundation
2024-03-12Grant· $2.6M
2023-04-20Grant· $5M
2022-09-19Grant· $8M
Recent News
2025-12-10
2025-12-01
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