Study Coordinator
University of North Carolina at Chapel Hill

Department:

LCCC - Clinical Trials-426806

Research Professionals

No

11/25/2024

12/09/2024

Permanent Staff (SHRA)

Soc/Clin Research Specialist - Journey

GN11

Study Coordinator

20020247

P019888

Full-Time Permanent

40

Monday - Friday, 8:30AM - 5:00PM

Chapel Hill, NC

North Carolina, US

$63,875 - $75,100

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

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 47 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.

The UNC/LCCC Protocol Office is an established clinical facility designed to serve as a core resource for the development and conduct of oncology clinical research for investigators in all disciplines. The Protocol Office staff, are responsible for protecting the safety of patients, ensuring the quality of the research, and safeguarding the interests of the University. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the process of development, approval and implementation of protocols conducted at UNC-CH and its affiliate institutions. The Protocol Office also provides guidance and input focused on clinical research systems development and decision-making and is a liaison with the hospital pharmacy, laboratory, radiology, clinics, public relations, and medical records department for protocol-related activity and information. In addition, the Protocol Office 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. 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.

The primary responsibilities of this position include the informed consent process, eligibility and screening, toxicity assessment, patient management, conducting in-services for nurses staff in treating clinic; planning of patient recruitment methods; logistics of patient visits; logistics of obtaining and coordinating clinical samples; specimen collection as needed, enlistment of support of necessary ancillary departments; coordinating the ordering of the required supplies; preparation of study tubes, collecting source documentation; Data entry I management for assigned studies, working with Clinical Research Associates to facilitate data collection for CRFs (case report forms} and/or eCRFs for trials as assigned; prepare and participate in monitoring visits; facilitate pre-site meetings, site initiation meetings, and plan, organize and run protocol start-up meetings.

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; strong computer skills; ability to gather data and document procedures; ability to plan work and coordinate multiple projects; customer oriented and ability to work in a team environment; ability to communicate effectively and professionally verbally and in writing. Requires study coordinator experience or experience in oncology clinical trials.

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. SOCRA/ACRP Certification. Previous study coordinator experience to include exposure to oncology clinical trials or directly related oncology study coordinator experience.

Not Applicable.

Clinic - UNCH or ACC, Evening work occasionally, Exposure to Bloodborne Pathogens, Exposure to Hazardous Materials, Overtime occasionally, Weekend work occasionally