Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit's business needs.

The Lead Clinical Research Coordinator will oversee the Coastal Carolina Children's Research Institute (CCCRI) developmental activities, working closely with CCCRI leadership to coordinate the program, including alignment of Novant Health/NHRMC operational systems with UNC research to bolster these efforts including establishment of the Wilmington PedsCRU that will support industry-funded clinical trials. They will receive asthma- research specific training, assist in meetings and follow-up of CCCRI initiatives, help with activities in developing a practice-based research network regionally, and will serve as lead coordinator for the local conduct of a PCORI-funded study and a NIAID-funded study.

The team lead will be a resource for the growing Clinical/Social Research Specialist team in Wilmington and will administer and provide technical expertise for research projects across Divisions in the Department of Pediatrics, including but not limited to: Endocrinology, Gastroenterology, Rheumatology, Allergy/Immunology, Critical Care. The primary purpose of this position is to provide leadership and oversight to all research occurring in Wilmington and to assist the Directors, as necessary, with any and all aspects of CRI research management. Applicants should reside in or be willing to travel frequently to Wilmington.

The Clinical/Social Research Specialist will work closely with the Leadership Team of PedsCRU and report directly to the Director of PedsCRU.

Ideal candidate has demonstrated ability to multitask and work on different projects concurrently. In addition to demonstrated ability to work on projects in different phases of completion (eg, start-up, actively recruiting, data analysis) and provide seamless coverage in taking on and handing off studies, to minimize disruption in project.

Experience with clinical research (including the UNC IRB processes, FDA regulatory requirements, ICH GCP guidelines, ACRP or SOCRA certification) is strongly desired.

The candidate should have excellent verbal and written communication skills with ability to interact with clinical investigators, laboratory personnel, study sponsors, IRB, Office of Clinical Trials, and support staff. Working knowledge of medical terminology, techniques and methodologies used in developing, coordinating and managing clinical research projects. Applicant must have a working knowledge of FDA Code of Federal Regulations (CFR) and International Conference on Harmonisation Good Clinical Practice (ICH GCP) as well as familiarity with local, state and federal guidelines governing clinical trials. The candidate must be experienced in initiating, maintaining and updating protocols with central and local IRBs and minting the appropriate regulatory documents. Applicant should have a working knowledge of database management and spreadsheets. Ability to learn quickly, work independently and efficiently with minimal supervision, prioritize tasks, and work under deadline pressure. Leadership experience is necessary. Flexibility is required for intermittent evening and weekend hours as needed for patient enrollment after normal business hours.

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.