SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.
???Study Conduct/ Clinical Research Practice Provide technical and clerical support in the conduct of clinical studies. Assist clinical research personnel in the implementation of clinical research studies, including procedures and project work. Comply with established standards for Good Clinical Practice (GCP). Maintain inventory of supplies and equipment. Operate standard laboratory equipment, if applicable.
???Regulatory Compliance and Documentation 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 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 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. Assemble training materials in preparation and conduct of clinical trials.
???Recruitment/Enrollment/Retention Assist in the screening, recruitment and enrollment of study participants. Coordinate and plan study visits, travel arrangements, provide instructions and reimbursement to study participants. Maintain status of all active studies. Assist with the identification of potential eligible participants for non-complex study protocols. Assist with the conduct of pre-consent screening according to protocol specifications to determine eligibility. Participate in the review of the consent form with participants. Complete the informed consent process according to GCP, CCHMC procedures and other applicable policies for non-complex protocols. 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.
???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 and develop rapport with study participants
???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.
??? High school diploma or equivalent ??? No directly related experience
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