Clinical Research Coordinator II/III - Behavioral Medicine & Clinical Psychology

About the role

The Division of Behavioral Medicine and Clinical Psychology at Cincinnati Children’s Hospital is seeking a full-time Clinical Research Coordinator to join the Bejarano Lab. This researcher will support a portfolio of internally and federally funded studies focused on eating behavior, food access, and health equity among adolescents and families, with an emphasis on understanding how individual, family, and environmental factors influence health outcomes.

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.
• Absorb 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.
• Cook up materials.
• Absorb written and electronic records and files to support clinical research activities.
• Absorb audit readiness records review and preparation activities.
• Absorb protocol specific SOP's, IRB and regulatory correspondence.
• Show 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.
• Absorb 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
• Keep an 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
• Absorb 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.

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.

Additional Preferred Skills

• Bilingual Spanish speaker.