Clinical Research Coordinator II

Job Responsibilities Assist in coordinating studies by preparing personnel and materials, preparing protocols, informed consents, amendments and other necessary documents for review by IRB and Sponsor. Assemble lab kits and/or gather supplies, collect and label samples, deliver or process samples in accordance with protocol, manual of operations, SOP, or other work instructions. 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 take the initiative to complete them. Coordinate and participate in 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. Assist with maintaining protocol‑specific SOPs, IRB and regulatory correspondence. Demonstrate awareness of federal regulations, state and local law, GCP/ICH and CCHMC policies to promote ethical practices and ensure compliance. Recognize importance of reporting concerns of ethical or regulatory issues to supervisor in a timely manner. Assist with documentation of regulatory activities and maintenance of regulatory binder in keeping with institution and division SOPs. Seek 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 professionally. Conduct pre‑consent screening procedures to determine eligibility. Review consent form with participant and allow time to consider participation. Execute informed consent process according to GCP, CCHMC procedures and other applicable policies. Communicate with participants’ clinical team regarding study participation as indicated by protocol. Document in applicable systems participants approached, screened and enrolled. Communicate recruitment and retention challenges to study leadership and provide recommendations to improve recruitment and retention. Assist with organizing and filing all correspondence. Refer questions and issues that arise during study conduct to 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 rapport. 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 for completeness, accuracy and compliance with GCP. Enter data into audited databases or electronic data‑capture systems. Maintain internal record‑keeping system(s) with study team members. Ensure accuracy of documentation from sources. Perform quality checks. Review reports, tables and listings. Support data‑management process for clinical research projects, including addressing data queries from data managers, project statisticians and sponsors. Job Qualifications 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. Primary Location South Campus Schedule Full time Shift Day (United States of America) Department Behavioral Med-Clin Psychology Employee Status Regular FTE 1 Weekly Hours 40 Expected Starting Pay Range Annualized pay may vary based on FTE status: $24.46 - $27.73 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. #J-18808-Ljbffr Cincinnati Children's