Clinical Research Coordinator III/IV - Allergy Department - Risma Lab

Cincinnati Children's

1d•$56,784 - $80,558

About The Position

The Clinical Research Coordinator will join the Risma Lab in the Division of Allergy and Immunology at Cincinnati Children’s. The lab conducts clinical and translational research to improve the diagnosis, treatment, and understanding of adverse drug reactions, including reactions to antibiotics, biologics, chemotherapy agents, vaccines, and other medications. The role supports patient-centered research and advances understanding of immune-mediated medication reactions. The coordinator oversees and supports clinical studies from study setup and participant recruitment through study conduct, regulatory compliance, data management, and closeout. Responsibilities include coordinating study visits and specimens, maintaining regulatory and study records, supporting informed consent and participant retention, communicating with investigators and study partners, and ensuring accurate and complete research data. The coordinator also serves as a resource for other research professionals and may train staff in clinical trial procedures. The position is listed as CRC III/IV. Requirements differ by level: CRC III requires a related bachelor’s degree and one year of directly related experience, or a related master’s degree. CRC IV requires a related bachelor’s degree and three years of experience in a related job discipline, or a related master’s degree and two years of related experience. CRC IV hires must obtain Certified Clinical Research Coordinator certification within 18 months of external hire.

Requirements

CRC III: Bachelor’s degree in a related field and one year of directly related work experience, or a master’s degree in a related field.
CRC IV: Bachelor’s degree in a related field and three years of experience in a related job discipline, or a master’s degree and two years of experience in a related job discipline.
CRC IV: Certified Clinical Research Coordinator certification required within 18 months of external hire date.

Responsibilities

Monitor the status of active studies and arrange study facilities and supplies.
Coordinate participant visits and study procedures, including specimen collection, processing, labeling, delivery, logging, handling, and storage.
Define specimen procedures with the study team and train staff on protocol-compliant sample handling as needed.
Maintain records and files required by sponsors and regulatory agencies, and serve as a resource to other clinical research professionals.
Collaborate with investigators and coworkers to support the progress and completion of clinical studies; train new staff in clinical trial preparation and conduct.
Prepare, submit, and maintain regulatory submissions, including new studies, annual reviews, amendments, adverse events, and study closeout activities.
Self-audit records and prepare for, participate in, and support monitor visits, audits, and quality reviews.
Coordinate review of research protocols with regulatory authorities and any additional divisions, agencies, or consultants as required.
Apply legal, regulatory, and policy requirements to promote ethical human research and document regulatory activities in appropriate systems.
Maintain accurate written and electronic research records and keep knowledge of regulatory requirements current.
When needed, communicate on behalf of the PI with sponsors, other divisions, or institutions to coordinate studies and resolve issues.
Determine participant identification methods, prepare recruitment materials or processes, and maintain participant tracking systems.
Identify potentially eligible participants, conduct pre-consent screening, review consent forms, and carry out informed consent according to applicable procedures and regulations.
Communicate with participants’ clinical teams and study leadership; document participants approached, screened, and enrolled in applicable systems.
Monitor recruitment and retention, report progress and challenges, recommend improvements, and work with study staff to address barriers.
Compose, organize, and maintain correspondence; follow through on questions and issues arising during study conduct.
Serve as a liaison with internal departments, clinical teams, regulatory agencies, medical offices, clinics, government agencies, academic centers, and other organizations.
Communicate study-related matters to investigators, sponsors, coordinating centers, research and clinical teams, managers, and other institutions; develop rapport with participants.
Create case report forms (CRFs) with team members as needed and complete CRFs and source documentation in accordance with applicable human research guidelines.
Review CRFs and source documentation for completeness, accuracy, and Good Clinical Practice compliance.
Enter or oversee entry and validation of data in auditable databases and electronic data-capture systems; perform data cleaning and quality checks.
Support data management, including responding to data queries, reviewing reports, tables, and listings, assisting with data analysis, and maintaining study data records and storage.
Maintain master database files and prepare reports from validation studies.