Clinical Research Coordinator II/III - Rheumatology

Cincinnati Children's

4d•$24•Onsite

About The Position

This role involves assisting in the coordination of clinical research studies within the Rheumatology department. Responsibilities include preparing study documents, managing samples, ensuring regulatory compliance, recruiting and retaining participants, managing data, and maintaining effective communication with all stakeholders. The position requires a strong understanding of clinical research practices, regulatory guidelines, and data management principles.

Requirements

High school diploma or equivalent (Required for CRC II)
2 years of work experience in a related job discipline (Required for CRC II)
Bachelor's degree in a related field (Required for CRC III)
1 year of directly related work experience (Required for CRC III, if Bachelor's degree obtained)
Master's degree in a related field (Required for CRC III, if no work experience required)

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, and amendments for IRB and Sponsor review.
Assemble lab kits and gather supplies.
Collect, label, and process samples according to protocol, manual of operations, SOPs, or other work instructions.
Ensure specimens are properly logged, handled, and stored.
Follow directions from supervisors and other research personnel.
Assist other staff members and coordinators in implementing studies.
Maintain inventory of supplies and equipment.
Operate standard laboratory and research study equipment.
Troubleshoot and correct erroneous results or equipment problems.
Identify and complete regulatory activities.
Coordinate and participate in the assembly of materials for regulatory submissions.
Maintain up-to-date and accurate written and electronic records and files.
Assist with audit readiness, records review, and preparation.
Maintain 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 in a professional manner.
Conduct pre-consent screening procedures to determine eligibility.
Review consent forms with participants and allow 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.
Provide recommendations to improve recruitment and retention to study leadership.
Organize and file all correspondence.
Refer questions and issues to the appropriate research team member.
Maintain awareness of study-related issues involving investigators, sponsors, and other stakeholders.
Maintain relationships with participants and develop rapport.
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 guidelines.
Review CRFs for completeness, accuracy, and GCP compliance.
Enter data into various auditable databases or electronic data-capture systems.
Maintain internal record-keeping systems.
Ensure accuracy of documentation from sources.
Perform quality checks to ensure data accuracy.
Review reports, tables, and listings.
Address data queries from data managers, statisticians, and sponsors.