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

Children's Hospital Medical Center; Cincinnati (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

Cincinnati Children's in Cincinnati, Ohio, is seeking an experienced Clinical Research Coordinator to support allergy and immunology studies. You will oversee study conduct, participant visits, and regulatory compliance in a patient-centered research environment.

The role involves coordinating with investigators, training staff, managing samples and data, and ensuring adherence to SOPs and GCP. Join a dedicated team advancing immune-mediated adverse drug reaction research.

Responsibilities

• Maintain status of all active studies; arrange facilities and supplies.
• Ensure participant and study compliance, including specimen collection and visits.
• Define specimen collection, processing and storage procedures with the study team.
• Train staff to collect, label, and process samples per protocol and SOPs.
• Maintain records required by regulatory agencies and sponsors.
• Department liaison: communicate with investigators, sponsors and teams.

Job description

Primary Location

Location S Department

Allergy Shift

Day (United States of America) Schedule

Full time Weekly Hours

40 FTE

1 Employee Status

Regular

Join the Risma Lab in the Division of Allergy and Immunology at Cincinnati Children's as an experienced Clinical Research Coordinator. The lab conducts clinical and translational research focused on improving the diagnosis, treatment, and understanding of adverse drug reactions, including reactions to antibiotics, biologics, chemotherapy agents, vaccines, and other medications. This role offers the opportunity to support meaningful, patient-centered research while helping advance our understanding of immune-mediated reactions to medications.

JOB RESPONSIBILITIES

Study Conduct/ Clinical Research Practice

Maintain awareness of status of all active studies. Arrange for facilities and supplies. Ensure participant and study compliance, i.e. collection of study specimens, and study visits. Work with study team as needed to define specimen collection, processing and storage procedures. Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set. Ensure specimens are properly logged, handled and stored. Maintain all records and files required by regulatory agencies and sponsors. Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial. Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies. Train new staff in preparation and conduct of clinical trials.

Regulatory Compliance and Documentation

Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties. Periodically self-audit records to ensure audit-readiness. Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner. Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, e.g. the need for review by additional divisions, regulatory agencies, or consultants, & coordinate the process to meet these requirements. Apply legal, regulatory & policy parameters to promote ethical practices in research involving human participants & to ensure compliance to those regulations. Document the conduct of each protocol's regulatory activities in appropriate systems. Maintain up-to-date & accurate written & electronic records & files to support clinical research activities. Continuously update knowledge of regulatory requirements. May act on behalf of the PI in communicating with sponsor, other divisions or institutions to coordinate studies & follow through on issues.

Recruitment/Enrollment/Retention

Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI and or management. Identify potentially eligible participants. Conduct pre-consent screening to determine eligibility. Review consent form with participant and provide time for participant to consider study participation. Execute the informed consent process according to GCP and CCHMC procedures and other applicable rules, regulations and policies. Communicate with participants' clinical team regarding study participation. 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. Make recommendations to improve recruitment and retention to the study leadership. Engage study staff to assist in identifying and enrolling participants. Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them.

Communication

Compose, document, organize, and maintain all correspondence. Oversee and follow through on questions and issues that arise during study conduct. Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's offices, city clinics, government agencies, academic centers, and other organizations. Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical and research teams, managers and other institutions. Develop a rapport with study participants.

Data Management

Create CRFs in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry. Complete Case Report Form