Clinical Research Coordinator II/III - Rheumatology

Cincinnati Children's

3d•$50,877 - $62,150

About The Position

The Clinical Research Coordinator II/III in Rheumatology assists with the conduct of clinical research studies, including study preparation, protocol and consent document preparation, specimen handling, regulatory documentation, participant recruitment and retention, study communications, and data management. The role follows study protocols, manuals of operation, standard operating procedures, Good Clinical Practice (GCP), applicable regulations, and institutional policies. It works under the direction of the clinical research coordinator or other members of the research team and supports study implementation, audit readiness, participant interactions, and accurate research records.

Requirements

For CRC II: High school diploma or equivalent and 2 years of work experience in a related job discipline.
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.

Nice To Haves

For CRC II: Bachelor’s degree in a related field.

Responsibilities

Assist with coordinating studies by preparing personnel and materials and preparing protocols, informed consents, amendments, and other documents for IRB and Sponsor review.
Assemble lab kits and supplies; collect, label, log, handle, store, deliver, or process samples as instructed by study protocols and procedures.
Follow direction from clinical research coordinators and other research staff, and assist team members with study implementation.
Maintain inventory of supplies and equipment; operate standard laboratory and study equipment when applicable, and troubleshoot equipment problems or erroneous results.
Identify regulatory activities and take initiative to complete them; coordinate and participate in assembling regulatory materials.
Maintain accurate written and electronic records, files, protocol-specific SOPs, IRB and regulatory correspondence, and regulatory binders; assist with audit-readiness review and preparation.
Follow applicable regulations, laws, GCP/ICH, and institutional policies; report ethical or regulatory concerns to a supervisor in a timely manner and seek research education opportunities.
Maintain awareness of active-study status, identify potentially eligible participants, coordinate and conduct study visits, provide participant instructions and reimbursement, and approach participants and families professionally.
Conduct protocol-specific pre-consent screening, review consent forms, allow participants time to consider participation, and conduct informed consent in accordance with GCP and applicable procedures.
Communicate with participants’ clinical teams when required by the protocol; document participants approached, screened, and enrolled in applicable systems.
Communicate recruitment and retention challenges to study leadership and recommend improvements.
Organize and file correspondence; refer study questions and issues to appropriate research team members and maintain awareness of study-related issues across investigators, sponsors, coordinators, clinical teams, and other institutions.
Build rapport with participants, contribute to division discussions, and participate in activities to improve organizational performance and study conduct.
Complete case report forms (CRFs) and source documentation in compliance with applicable human research guidelines; review CRFs for completeness, accuracy, and GCP compliance.
Enter data into auditable databases or electronic data-capture systems, maintain internal study records, verify source documentation, and perform data quality checks.
Review reports, tables, and listings and support clinical research data management, including responses to data queries from data managers, statisticians, and sponsors.