UTS - Temporary Study Coordinator at UNC Chapel Hill

UNC-Chapel Hill•Chapel Hill, NC

1d•Onsite

About The Position

The Study Coordinator independently coordinates and manages multiple oncology clinical trials throughout the study lifecycle, including activation, enrollment, conduct, monitoring, and closure. The role works closely with Principal Investigators, research staff, sponsors, and clinical teams to ensure studies comply with protocol requirements, Good Clinical Practice (GCP), federal regulations, and institutional policies. It involves direct patient interaction and coordination of research activities across UNC Medical Center, UNC-Chapel Hill campus locations, and affiliated clinics. This is a fully onsite position in Chapel Hill, North Carolina. The standard schedule is Monday through Friday, 8 a.m. to 5 p.m.; occasional evening, weekend, or holiday work may be required to support study activities. The position involves regular interaction with patients and clinical staff in healthcare and research settings, and possible exposure to bloodborne pathogens, biohazardous specimens, and other healthcare-related materials.

Requirements

Bachelor’s degree in a related scientific, healthcare, or research discipline from an accredited institution.
One year of relevant experience.
Knowledge of ICH GCP, federal regulations, and clinical protocols.
Effective verbal and written communication skills.
Strong computer skills and the ability to manage multiple projects.
Demonstrated decision-making and problem-solving capabilities.
High attention to detail in data gathering, documentation, and procedures.
Ability to work collaboratively in a team environment with a customer-oriented mindset.
Ability to work onsite at UNC Medical Center, UNC-Chapel Hill campus, and satellite clinics.
Availability for occasional evening, weekend, and holiday work.

Nice To Haves

Experience as a study coordinator or in oncology clinical trials.
Familiarity with Phase I–III clinical research, including investigational drugs and devices, and translational trial experience.
Prior experience independently coordinating complex studies.
SOCRA or ACRP certification.
Familiarity with medical terminology, data abstraction, and navigating medical records.

Responsibilities

Independently manage multiple oncology clinical trials from study startup through 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.
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.
Maintain accurate and complete source documentation.
Enter study data into electronic data capture systems and case report forms, and 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.
Coordinate the collection, processing, storage, and shipment of research specimens.
Maintain specimen accountability and tracking documentation, and collaborate with investigators and laboratory personnel regarding specimen analysis and study requirements.
Follow biohazard handling and shipping procedures.
Ensure compliance with GCP, FDA and federal research regulations, IRB requirements, sponsor requirements, and 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.
Review billing calendars and study-related financial documentation, submit participant reimbursement paperwork, and ensure study visits are appropriately linked in the electronic medical record system.
Track time and effort reporting as required, and support study-related administrative functions and reporting.
Serve as a primary contact for assigned clinical trials.
Collaborate 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.