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

CO00 Children's Hospital Medical Center; Greendale (WI); On-site; USD 34,000 - 36,000; Full time

Job summary

Cincinnati Children’s Hospital Medical Center is seeking a Clinical Research Coordinator to support the International DIPG Registry, coordinating with sites across the U.S. and internationally.

You will manage regulatory documents, assist with IRB processes, and support data collection and enrollment for pediatric oncology research. The role emphasizes coordination, organization, and collaboration within a research team, with responsibilities spanning study conduct, regulatory compliance,

Qualifications

• High school diploma or equivalent required for CRC II; 2 years of related work experience.
• CRC III requires a Bachelor's in a related field and 1 year of related experience, or a Master's degree.

Responsibilities

• Coordinate studies by preparing protocols, informed consents, amendments and regulatory documents for IRB review.
• Maintain regulatory records, SOPs, and regulatory correspondence to ensure compliance.
• Identify eligible participants and manage recruitment, enrollment, and retention activities.
• Complete Case Report Forms and data entry; ensure data accuracy and respond to data queries.

Skills

Regulatory knowledge

Data entry accuracy

Education

Bachelor's degree in a related field

Master's degree in a related field

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. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors.

JOB QUALIFICATIONS

Required for CRC II: High school diploma or equivalent, and 2 years of work experience in a related job discipline. Preferred: Bachelor's degree in a related field. Required for CRC III: Bachelor's degree in a related field, and 1 year of directly related work experience, or a Master's degree in a related field. Expected Starting Salary Range: CRC II: $24.46/hr – $26.47/hr CRC III: $56,784.00 - $63,960.00

About Us

At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.

Cincinnati Children's is: Recognized by U.S. News & World Report as atop 10 best Children's Hospitals in the nation for more than 15 years Consistently among the top 3 Children's Hospitals for National Institutes of Health (NIH)Funding Recognized as one of America’s Best Large Employers (2025), America’s Best Employers for New Grads (2025) One of the nation'sAmerica’s Most Innovative Companiesas noted by Fortune Consistently certified as great place to work A Leading Disability Employeras noted by theNational Organization on Disability Magnet® designated for the fourth consecutive time by theAmerican Nurses Credentialing Center (ANCC) We Embrace Innovation—Together. We believe in empowering our teams with the tools that help us work smarter and care better. That’s why we support the responsible use of artificial intelligence. By encouraging innovation, we’re creating space for new ideas, better outcomes, and a stronger future—for all of us. Comprehensive job description provided upon request.

Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status.

EEO/Veteran/Disability Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status.

Completion of Application You will be asked to fully complete each page of the application to the best of your knowledge. Failure to complete all parts of the application will result in a delay in processing and/or rejection of the application.

Need Assistance or Accommodation? Assistance with Application: For assistance or technical support, visit our FAQ page or email [e-mail]. Accommodation: We provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. If you require an accommodation in the application process, email [e-mail].