UTS - Temporary Study Coordinator at UNC Chapel Hill

University of North Carolina - Chapel Hill; Elkins Hills (NC); On-site; USD 60,000 - 95,000; Full time

Benefits offered by this job

Discounts at local retailers and arts

Child care savings

Performing arts event discounts

Job summary

University of North Carolina at Chapel Hill is seeking a dedicated Study Coordinator to oversee oncology clinical trials across UNC Medical Center and clinic sites. The role involves direct patient interaction, study activation, enrollment, and coordination with investigators and sponsors.

The position requires a Bachelor’s degree in a related field and one year of relevant experience, with strong regulatory knowledge and data management capabilities.

Qualifications

• Bachelor's degree in related scientific, healthcare, or research discipline is required.
• Experience coordinating oncology clinical trials is preferred.
• Strong knowledge of GCP, regulatory requirements, and study documentation.

Responsibilities

• Coordinate multiple oncology trials from startup through closeout.
• Identify and enroll eligible participants and obtain informed consent.
• Maintain source documentation and data entry in EDC systems; monitor data queries.
• Coordinate biospecimen collection, processing, storage, and shipping as required.
• Ensure regulatory compliance, reporting of SAEs, and support audits and visits.
• Support study finances, billing calendars, and reimbursements where applicable.
• Collaborate with investigators, sponsors, staff, and clinics; assist training and onboarding.

Skills

Clinical coordination

Oncology trials

Regulatory knowledge

Attention to detail

Communication skills

Education

Bachelor's degree in related scientific, healthcare, or research discipline

Tools

Electronic data capture systems

Medical records navigation

Job description

Be a Tar Heel!

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 that include numerous retail and restaurant discounts, savings on local child care centers and special rates for performing arts events.

Position Summary

The Study Coordinator is responsible for independently coordinating and managing multiple oncology clinical trials throughout the study lifecycle, including activation, enrollment, conduct, monitoring, and closure. This position works closely with Principal Investigators, research staff, sponsors, and clinical teams to ensure studies are conducted in accordance with protocol requirements, Good Clinical Practice (GCP), federal regulations, and institutional policies.

The role requires direct patient interaction and coordination of research activities across UNC Medical Center, UNC-Chapel Hill campus locations, and affiliated clinics.

Clinical Trial Coordination

• Independently manage multiple oncology clinical trials from startup through study closeout.
• Maintain a comprehensive understanding of assigned study protocols and sponsor requirements.
• Coordinate study activation, implementation, monitoring, and closure activities.
• Participate in site initiation visits, startup meetings, monitoring visits, and closeout visits.
• Maintain study documentation and regulatory records.

Participant Recruitment and Management

• Identify, screen, recruit, and enroll eligible research participants.
• Conduct informed consent discussions and document patient participation.
• Coordinate and schedule protocol-required study visits.
• Provide participant education and study-related support.
• Monitor participant safety and communicate study requirements throughout participation.

Data Collection and Documentation

• Maintain accurate and complete source documentation.
• Enter study data into electronic data capture systems and case report forms.
• Resolve data queries within established timelines.
• Maintain screening logs, enrollment records, and study tracking tools.
• Create and review study-specific source documents and data collection materials.
• Participate in routine monitoring visits and audits

Biospecimen and Laboratory Support

• Coordinate collection, processing, storage, and shipment of research specimens.
• Maintain specimen accountability and tracking documentation.
• Collaborate with investigators and laboratory personnel regarding specimen analysis and study requirements.
• Ensure compliance with biohazard handling and shipping procedures.

Regulatory Compliance

• Ensure compliance with:
  • Good Clinical Practice (GCP)
  • FDA and federal research regulations
  • Institutional Review Board (IRB) requirements
  • Sponsor requirements
  • UNC policies and procedures
• Report serious adverse events within required timelines.
• Assist with protocol deviation reporting and corrective action plans.
• Prepare for and support study monitoring visits and audits.

Financial and Administrative Responsibilities

• Review billing calendars and study-related financial documentation.
• Submit participant reimbursement paperwork.
• Ensure study visits are linked appropriately within the electronic medical record system.
• Track time and effort reporting as required.
• Support study-related administrative functions and reporting.

Team Collaboration

• Serve as a primary contact for assigned clinical trials.
• Work collaboratively with investigators, sponsors, research staff, nursing teams, and clinic personnel.
• Assist in training and onboarding new staff members.
• Support development of investigator-initiated studies and study materials.
• Participate in process improvement and quality initiatives.

Minimum Qualifications

Bachelor's degree in related scientific, healthcare, or research discipline and one year of relevant experience; All degrees must be obtained from accredited institutions. Having a degree is a requirement for this position and a rule from the State.

Manager Preferences

• Clinical Research Expertise: Candidates must have experience as a study coordinator or in oncology clinical trials, with strong preference for those familiar with Phase I-III clinical research to include investigation drugs and devices, as well as translational trial experience. Prior involvement coordinating complex studies independently is preferred.
• Regulatory and Technical Proficiency: Knowledge of ICH GCP, federal regulations, and clinical protocols is required, with a preference of SOCRA or ACRP certification. Candidates should have familiarity with medical terminology, data abstraction, and navigating medical records with high accuracy and attention to detail.
• Operational and Analytical Skills: Possess strong computer skills, the ability to manage multiple projects, and demonstrated decision-making and problem-solving capabilities. High attention to detail in data gathering and documentation or procedures is critical.
• Communication and Collaboration: Effective verbal and written communication skills are necessary, along with a customer-oriented mindset and the ability to work collaboratively in a team environment.
• Work Environment Flexibility: Candidates must be able to work on-site at UNC Medical Center, UNC Chapel Hill Campus, and satellite clinics, with occasional availability for evenings, weekends, and holidays.

Special Instructions

Under this partnership, UTS provides exclusive temporary staffing services to UNC-Chapel Hill and NC State, employing candidates to work as temporary employees in a variety of jobs on both campuses.

Quick Link

https://unc.peopleadmin.com/postings/327525

Temporary Employment Policies

http://hr.unc.edu/policies-procedures-systems/spa-employee-policies/temporary-employment/relevant-policy-information-for-temporary-employees/

Posting Contact Information

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at [phone] or send an email to [e-mail]

Equal Opportunity Employer Statement

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.