Cincinnati Children's Office of Academic Affairs and Career Development · 1 day ago
Clinical Research Coordinator II/III/IV - Allergy Department - Rothenberg Lab
Cincinnati, OH
Full-time
Onsite
Entry, Mid, Senior Level
$57K/yr - $62K/yr
2+ years expCincinnati Children's Office of Academic Affairs and Career Development is seeking a Clinical Research Coordinator for the Allergy Department. This role involves overseeing sample collection, patient enrollment, and ensuring compliance with clinical research protocols in a surgical environment.
Hospital & Health Care
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
Qualification
Required
High school diploma or equivalent, and 2 years of work experience in a related job discipline for CRC II
Bachelor's degree in a related field, and 1 year of directly related work experience, or a Master's degree in a related field for CRC III
Bachelor's degree in a related field with 3 years of experience in related job discipline or Master's degree and 2 years of experience in a related job discipline for CRC IV
Certified Clinical Research Coordinator within 18 months of external hire date for CRC IV
Preferred
Bachelor's degree in a related field for CRC II
Company
Cincinnati Children's Office of Academic Affairs and Career Development
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Cincinnati, Ohio, US
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase