Clinical Research Coordinator II/III - Oncology /Non-Therapeutic Registry

Children's Hospital Medical Center; Cincinnati (OH); On-site; USD 52,000 - 68,000; Full time

Job summary

Children's Hospital Medical Center is seeking a Clinical Research Coordinator to join the Oncology research team and support the International DIPG Registry. You will coordinate with sites across the U.S.

and internationally, assist with regulatory processes, and help manage day-to-day data operations for DIPG research. The role emphasizes collaboration, documentation, and participant coordination in a pediatric oncology setting.

Qualifications

• Coordinate studies by preparing protocols, consents, amendments for IRB and Sponsor.
• Assemble lab kits, collect and label samples per SOPs.
• Maintain regulatory records and ensure compliance with GCP/ICH.
• Recruit and enroll participants, document in systems and report challenges.

Responsibilities

• Study Conduct/ Clinical Research Practice - Coordinate studies by preparing personnel and materials, preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor.
• Regulatory Compliance and Documentation - Identify regulatory activities to be completed and takes the initiative to complete.
• Recruitment/Enrollment/Retention - Maintain awareness of status of all active studies. Identify potentially eligible participants.

Skills

Clinical research

Regulatory compliance

IRB coordination

Participant recruitment

Data management

Education

Bachelor's degree in life sciences

Tools

EDC systems

Job description

Primary Location

Location T Department

Oncology Department Shift

Day (United States of America) Schedule

Full time Weekly Hours

40 FTE

1 Employee Status

Regular

Join our Oncology research team as a Clinical Research Coordinator and play an important role in advancing the International DIPG Registry , a collaborative effort supporting research focused on diffuse intrinsic pontine glioma (DIPG). In this position, you will coordinate with participating sites across the U.S. and internationally, support day-to-day registry operations, facilitate data requests and data-sharing activities, and contribute to a variety of registry-based research projects. This is an excellent opportunity for an experienced clinical research professional who enjoys collaboration, organization, and supporting meaningful pediatric oncology research.

JOB RESPONSIBILITIES

• Study Conduct/ Clinical Research Practice - 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.
• Regulatory Compliance and Documentation - 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.
• Recruitment/Enrollment/Retention - 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.
• Communication - 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.
• Data Management - 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. Supp