Clinical Research Coordinator II​/III - Allergy - Devonshire Lab

The Devonshire Lab within the Division of Allergy and Immunology is dedicated to advancing the prevention, diagnosis, and treatment of food allergies in infants and young children. The lab conducts innovative clinical research focused on early‑life allergy prevention strategies, food allergy diagnostics, shared decision‑making in allergy care, and clinical trials evaluating novel interventions such as oral immunotherapy. The Clinical Research Coordinator will play a key role in supporting pediatric clinical research studies, collaborating with patients and families, research teams, and clinical providers to help improve outcomes for children at risk for or living with food allergies.

This position offers an exciting opportunity to contribute to groundbreaking research that is shaping the future of allergy prevention and management.

• Study Conduct/Clinical Research Practice – Maintain awareness of status of all active studies. Arrange for facilities and supplies. Ensure participant and study compliance, including specimen collection and study visits. Work with the study team to define specimen collection, processing, and storage procedures. Train others to collect and label samples and deliver or process them in accordance with protocol, manual of operations, standard operating procedures (SOP), or other work instruction sets.
  
  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 investigators and coworkers to ensure proper progress and completion of clinical studies. Train new staff in the preparation and conduct of clinical trials.
• Regulatory Compliance and Documentation – Prepare, submit and maintain all regulatory submissions (proposed new studies, annual review, amendments, and adverse events) accurately and within a timely manner to all collaborative parties. Periodically self‑audit records to ensure audit‑readiness. Prepare, plan, and participate in all monitor visits, audits, and quality reviews (internal and external) in a professional manner. Oversee the review, correspondence, and 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, and coordinate the process to meet these requirements. Apply legal, regulatory, and policy parameters to promote ethical practices in research involving human participants and to ensure compliance with those regulations. Document the conduct of each protocol’s regulatory activities in appropriate systems.
  
  Maintain up‑to‑date and accurate written and electronic records and files to support clinical research activities. Continuously update knowledge of regulatory requirements. May act on behalf of the PI in communicating with the sponsor, other divisions, or institutions to coordinate studies and follow through on issues.
• Recruitment, Enrollment, and Retention – Determine best methods to identify potential participants for a research protocol (advertisements, chart reviews, monitoring of clinic schedules, etc.) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report to the PI and/or management. Identify potentially eligible participants. Conduct pre‑consent screening to determine eligibility.
  
  Review the consent form with the participant and provide time for consideration of 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…