Lead Study Coordinator

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is one of 49 National Cancer Institute ( NCI)-designated comprehensive cancer centers in the country. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach. NC Lineberger's Clinical Protocol Office is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.

The purpose of this position is to facilitate the conduct of oncology clinical trials, including subject and data management, according to federal regulations, Good Clinical Practice, and local and institutional policies. Reporting to the Clinical Research Manager, the Lead Study Coordinator independently manages multiple complex trials through the protocol life cycles of activation, implementation and closure. As Lead Study Coordinator, provide team lead and programmatic support on a daily basis, lead patient care and advising activities and serve as preceptor for new hire; providing ongoing training and first line support for staff. These responsibilities relate to the mission of the UNC/ LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact research quality and safeguard institutional integrity.

Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

- Knowledge of ICH GCP, Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols.
- Advanced knowledge of clinical research coordination.
- Possess strong decision-making skills and the ability to problem solve and troubleshoot issues.
- High level of accuracy and attention to detail.
- Strong computer skills.
- Ability to gather data and document procedures.
- Ability to plan work and coordinate multiple projects.
- Ability to contribute to preparation and delivery of reports, trainings and SOPs.
- Customer oriented and ability to work in a team environment.
- Ability to communicate effectively and professionally verbally and in writing.
- Ability to work on evenings, weekends and/or holidays occasionally required.

- Previous experience with therapeutic clinical research involving drugs and/or devices.
- Experience in Phase I, II, and III clinical research.
- Experience navigating medical records and data extraction.
- Clinical trial coordination experience, including oncology.
- SOCRA/ ACRP Certification.

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.