Clinical Research Coordinator II/III - Behavioral Medicine & Clinical Psychology (Beebe Lab)

Cincinnati Children's

11d•$50,877 - $63,960•Onsite

About The Position

This position involves assisting in the coordination of clinical research studies within the Behavioral Medicine & Clinical Psychology department, specifically in the Beebe Lab. The role requires a blend of administrative, clinical, and data management tasks to ensure studies are conducted efficiently and ethically. The Clinical Research Coordinator will support study protocols, manage documentation, interact with participants, and maintain accurate records.

Requirements

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).
Demonstrated awareness of federal regulations, state and local law, GCP/ICH and CCHMC policies.
Ability to recognize the importance of reporting concerns of ethical and/or regulatory issues to supervisor in a timely manner.
Ability to approach potential participants and families in a professional manner.
Ability to execute the informed consent process according to Good Clinical Practices (GCP), CCHMC procedures and other applicable policies.
Ability to communicate with participants' clinical team regarding study participation as indicated by protocol and/or manual of operations.
Ability to document in applicable systems (tracking, electronic health, etc.) participants approached, screened and enrolled in the study.
Ability to communicate challenges with recruitment and retention to the study leadership.
Ability to provide recommendations to improve recruitment and retention to the study leadership.
Ability to organize and file all correspondence.
Ability to refer questions and issues that arise during study conduct to the appropriate research team member.
Ability to maintain awareness of study related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions.
Ability to maintain relationship with participants.
Ability to develop a rapport with study participants.
Ability to provide input to division discussions related to clinical research studies.
Ability to participate in meetings, discussions and activities designed to improve organizational performance through recommending areas or approaches for improving study conduct.
Ability to complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines for human research.
Ability to review CRFs to ensure completeness, accuracy and compliance with Good Clinical Practice.
Ability to enter data into various auditable databases or electronic data-capture systems.
Ability to maintain internal record keeping system(s) in conjunction with study team members.
Ability to ensure accuracy of documentation from sources.
Ability to perform quality checks to ensure accuracy of data.
Ability to review reports, tables, and listings.
Ability to support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors.

Nice To Haves

Bachelor's degree in a related field (preferred for CRC II).

Responsibilities

Assist in coordinating studies by preparing personnel and materials, protocols, informed consents, amendments, and other necessary documents for IRB and Sponsor review.
Assemble lab kits and gather supplies.
Collect, label, and process samples in accordance with protocol, manual of operations, SOP, or other work instructions.
Ensure specimens are properly logged, handled, and stored.
Follow directions from supervisors and other staff involved in clinical research projects.
Assist other staff members and coordinators in implementing studies.
Maintain inventory of supplies and equipment.
Operate standard laboratory and research study equipment, if applicable.
Troubleshoot and correct erroneous results or equipment problems.
Identify and complete necessary regulatory activities.
Coordinate and participate in the assembly of materials for regulatory submissions.
Assist in maintaining up-to-date and accurate written and electronic records and files.
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.
Report 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.
Seek out research educational opportunities.
Maintain awareness of the status of all active studies.
Identify potentially eligible participants.
Coordinate, plan, and execute study visits, providing instructions and reimbursement to participants.
Approach potential participants and families professionally.
Conduct pre-consent screening procedures to determine eligibility.
Review consent forms with participants and provide time for consideration.
Execute the informed consent process according to GCP, CCHMC procedures, and applicable policies.
Communicate with participants' clinical teams regarding study participation as indicated.
Document participant interactions (approached, screened, enrolled) in applicable systems.
Communicate recruitment and retention challenges to study leadership and provide recommendations for improvement.
Assist with organizing and filing all correspondence.
Refer questions and issues to the appropriate research team member.
Maintain awareness of study-related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical teams, managers, and other institutions.
Maintain relationships with and develop rapport with study participants.
Provide input to division discussions related to clinical research studies.
Participate in meetings and activities to improve organizational performance.
Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines.
Review CRFs for completeness, accuracy, and compliance with GCP.
Enter data into various auditable databases or electronic data-capture systems.
Maintain internal record-keeping systems in conjunction with study team members.
Ensure accuracy of documentation from sources.
Perform quality checks to ensure data accuracy.
Review reports, tables, and listings.
Address data queries from data managers, project statisticians, and sponsors.