UTS - Temporary Study Coordinator at UNC Chapel Hill

NC State University; Chapel Hill (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Attend sporting events for free

Childcare discounts

Job summary

NC State University is seeking a UTS - Temporary Study Coordinator at UNC Chapel Hill to independently coordinate multiple oncology clinical trials from startup through closeout. The role interfaces with investigators, sponsors, and clinical teams to ensure protocol compliance, GCP, and regulatory standards.

The position requires direct patient interactions, on-site work at UNC Medical Center and clinic locations, and a Monday–Friday schedule with flexibility for evenings or weekends as needed.

Qualifications

• Bachelor’s degree in related scientific, healthcare, or research discipline and one year of relevant experience.
• Experience in oncology clinical trials is preferred and highly valued.
• Knowledge of ICH GCP and FDA regulations is preferred.

Responsibilities

• Independently manage multiple oncology clinical trials from startup through closeout.
• Coordinate study activation, implementation, monitoring, and closure activities.
• Identify, screen, recruit, and enroll eligible participants and conduct informed consent discussions.
• Maintain source documentation and data entry in electronic systems with timely resolution of queries.
• Coordinate biospecimen collection, handling, storage, and shipping.
• Ensure regulatory compliance with GCP, IRB, sponsor requirements, and UNC policies.

Skills

Clinical research coordination

Study coordination

Communication skills

Regulatory knowledge

Education

Bachelor’s degree in related field

Tools

Epic/EMR

EDC/CRF

IRB knowledge

Job description

UTS - Temporary Study Coordinator at UNC Chapel Hill

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.

Is Time Limited

Is Time Limited Yes

If Yes, Appointment Length 6 months

Wolfpack Perks and Benefits

As a Pack member, you belong here, and can enjoy exclusive perks designed to enhance your personal and professional well-being. As you consider this opportunity, we encourage you to review our Employee Value Proposition and learn more about what makes NC State the best place to learn and work for everyone.

• Attend non-revenue generating sporting events for free.

Attain Work-life balance with our Childcare discounts , Wellness & Recreation Membership , and Wellness Programs that aim to build a thriving wolfpack community.

Disclaimer: Perks and Benefit eligibility is based on Part-Time or Full-Time Employment status. Eligibility and Employer Sponsored Plans can be found within each of the links offered.

Department Information

Job City & State

Department

System Information

Classification Title

Classification Title Temporary-Service Maintenance

Working Title

Working Title UTS - Temporary Study Coordinator at UNC Chapel Hill

Position Information

Requirements and Preferences

Work Schedule

Work Schedule Monday–Friday, 8:00 AM–5:00 PM, onsite

Other Work/Responsibilities

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.
• 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.

• 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.

This position is fully onsite in Chapel Hill, NC and requires regular interaction with patients and clinical staff in healthcare and research settings. Occasional evening, weekends, or holiday work may be required to support study activities. Exposure to bloodborne pathogens, biohazardous specimens, and other healthcare-related materials may occur as part of normal job responsibilities.

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

Ideal candidates should have:

• Oncology clinical research experience as a Study/Clinical Research Coordinator or similar role in other indications with investigational drugs/devices.
• Experience independently managing multiple clinical trials from startup through closeout.
• Knowledge of ICH - GCP and FDA regulations.
• Experience with patient screening, recruitment, informed consent, enrollment, and study visits.
• Data entry, source documentation, EDC / CRF , and EMR /Epic experience.
• Experience supporting monitoring visits, audits, protocol deviations, and AE/ SAE collection and reporting.
• Strong organization, attention to detail, problem-solving, and ability to manage competing priorities.
• Excellent communication and collaboration with investigators, sponsors, clinical teams, and patients.
• Experience in an academic medical center/cancer center or site level preferred.

Key Resume Search Terms

Oncology | Clinical Research Coordinator | Study Coordinator | Clinical Trials | Phase I/II/ III | Investigational Drugs/Devices | Translational Research | GCP | Patient Recruitment and Enrollment| Informed Consent | EDC | CRF | Data Entry | Epic/ EMR | Monitoring | Audits | Biospecimen management

We are looking for someone who can independently manage complex oncology trials, work directly with patients and clinical teams, and ensure high-quality, compliant study execution.

Department Required Skills

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 policy from the State.

Preferred Years Experience, Skills, Training, Education

• 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 necessary, along with a customer-oriented mindset and 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.

NC State University is an equal opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. The University encourages all qualified applicants, including protected veterans and individuals with disabilities, to apply. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-513-0574 to speak with a representative of the Office of Equal Opportunity.

If you have general questions about the application process, you may contact Human Resources at [phone] or [e-mail].

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.

NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.