Clinical Research Coordinator

UNC-Chapel Hill•Chapel Hill, NC

26d•Hybrid

About The Position

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. This position will serve as a Clinical Research Coordinator within the UNC Department of Pediatrics, Children’s Research Institute ( CRI ). The Clinical Research Coordinator is responsible for the planning, organization, and conduct of multiple clinical research study protocols, including independently collecting and recording data, project administration, and communication with various stakeholders. The role supports research on childhood diseases and disorders across the Department and University, fostering interdisciplinary collaboration to advance the health of children in NC and beyond. Research efforts involving pediatric populations are supported by the CRI Pediatric Clinical Research Unit (PedsCRU), which provides infrastructure such as program management, regulatory support, data management, sample processing, training, and space for study visits. The primary purpose of this position is to coordinate and manage multiple clinical trials, ensuring pediatric researchers have the resources needed to conduct studies. The Study Coordinator oversees day-to-day activities of several pediatric clinical trials involving both drugs and medical devices. Responsibilities include patient recruitment, study procedures, survey administration, and data collection and maintenance. The person in this position with navigate responsibilities based on protocols currently underway and those in development. Other responsibilities include the initiation and maintenance of IRB and other regulatory procedures.

Requirements

Strong written and verbal communication skills.
Must be able to work and communicate with diverse populations effectively and professionally.
Ability to work independently as well as function as part of a team.
Proficient with Microsoft Outlook, Excel, and Word.
The coordinator will demonstrate full knowledge of clinical research principles, methods of data collection and analysis.
The coordinator will demonstrate basic knowledge of statistics, computers, and related research equipment.
The coordinator must understand all aspects of GCP (Good Clinical Practice) to conduct clinical studies under the regulatory guidelines of the FDA and institutional IRB .
The coordinator must understand protocols and be able to teach them to faculty, fellows, and clinic personnel.

Nice To Haves

Candidates who have worked with children, built rapport with families of diverse backgrounds, and are self-motivated are highly sought.
Association of Clinical Research Professionals ( ACRP ) or the Society of Clinical Research Associates ( SOCRA ) certification is strongly desired.
recent direct experience with: Clinical trials (including experience with UNC IRB processes, FDA regulatory requirements, ICH GCP guidelines, and EPIC )
Evaluating protocols and consents for potential changes, when warranted, for feasible implementation at our study location in the targeted population
Coordinating NIH multi-center clinical trials, including study startup, recruitment, study management, data collection, and closeout
Competitive enrollment studies
Monitoring vital signs (heart rate, blood pressure)
Developing and negotiating budgets with industry partners