Clinical Research Coordinator II/lll/lV Allergy
Cincinnati Children's Hospital Medical Center
- Cincinnati, OH
- Permanent
- Full-time
- 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.
- 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.
- 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.
- 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.
- 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.