Leadership

Clinical Protocol Office StaffCarrie Lee, MD, MPH, Medical Director
Marie Malikowski, CCRP, Associate Director, Clinical Research Operations
Jared Weiss, MD, Associate Medical Director, Finance
Kim Keller, RN, MSN, OCN, Assistant Director, Clinical & Network Operations
Brian Kiley, MBA, Assistant Director, Finance
Mary O’Dwyer, MRP, CCRP, Assistant Director, Data Operations & Clinical Trials System

Services

The Clinical Protocol Office (CPO) consists of 75 healthcare professionals supporting the design and conduct of oncology clinical trials. The CPO is responsible for patient and study coordination-related activities; including subject evaluation and registration, toxicity assessment and safety monitoring of novel therapeutics and patient education. The CPO assists and facilitates protocol development, contract acquisition and management, regulatory oversight and compliance, preparation and submission of INDs for novel studies and novel compounds, internal and external study audits, quality control, and data acquisition, transcription and management. The CPO works with the Protocol Office Executive Committee (POEC), the Data Safety Monitoring Committee (DSMC), Compliance Committee (formerly the Oncology Protocol Audit Committee (OPAC), Committee), and the Protocol Review Committee (PRC) to assure patient eligibility and safety, regulatory compliance and quality, reproducible data.

Find a Clinical Trial

Location

Third floor, UNC Lineberger Comprehensive Cancer Center

Hours

Monday – Friday, 8:30 a.m. – 5:00 p.m.

Staff

  • Oncology Research Nurse Clinicians
  • Clinical Research Associates
  • Regulatory Associates
  • Financial Staff
  • Protocol Development Associates

For More Information

For questions regarding the Protocol Review Committee (PRC), contact Stacy Maxwell at stacy_maxwell@med.unc.edu or (919) 962-8566.  For questions regarding the Data and Safety Monitoring Committee (DSMC) or the Compliance Committee (formerly the Oncology Protocol Audit Committee), contact Beth Sappelt at beth_sappelt@med.unc.edu or (919) 843-8625.