Clinical Research Coordinator (Oncology)

This position involves independently managing multiple oncology clinical trials from startup through closeout while serving as the primary point of contact between patients, physicians, sponsors, research staff, and clinical teams.

Responsibilities

• Coordinate all phases of clinical trials, including activation, enrollment, conduct, monitoring, and study closure.

• Recruit, screen, consent, and enroll study participants.

• Schedule and manage protocol-required patient visits and follow-up appointments.

• Educate patients and serve as a study resource throughout participation.

• Enter study data into systems and maintain accurate source documentation.

• Manage regulatory records and ensure ongoing compliance with study requirements.

• Support sponsor monitoring visits, audits, and study inspections.

• Coordinate collection, processing, tracking, and shipment of research specimens.

• Report adverse events (AE/SAE), protocol deviations, and other study-related issues.

• Collaborate with investigators, sponsors, nurses, laboratory personnel, and research staff with study startup activities, closeout activities, and process improvement initiatives.

Essential Skills

• At least 1 year of Clinical Research Coordinator (CRC) or Study Coordinator experience.

• Experience in patient recruitment, screening, informed consent, enrollment, and scheduling.

• Proficiency with Electronic Data Capture systems (e.g., Medidata Rave, Oracle, Inform).

• Regulatory experience, including IRB submissions/maintenance and study documentation.

• Experience managing study data, source documentation, and case report forms (CRFs).

• Experience with monitoring visits, audits, and query resolution.

• Knowledge of GCP, FDA regulations, and clinical research compliance.

• Oncology and/or Cardiovascular/CNS experience.

Additional Skills & Qualifications

• Bachelor's degree in a scientific, healthcare, or research-related field (or equivalent experience).

• Experience supporting investigational drug and/or device studies.

• Epic/EMR experience preferred.

• SOCRA or ACRP certification.

• Experience in Phase I, II, and III clinical trials.

• Translational research experience.

• Experience independently managing multiple studies.

• Experience with protocol deviations, AE/SAE reporting, monitoring visits, and audits.

Work Environment

The position requires working 100% onsite 5 days per week within an academic medical center and oncology research setting, primarily with oncology/cancer patients. The role may include travel between UNC Medical Center, UNC-Chapel Hill campus locations, and affiliated clinics, with occasional flexibility required for evenings and weekends.