Assistant Director of Clinical Research Operations & Medical Center Integration
Clinical Protocol Office Leadership
Carrie Lee, MD, MPH
Dr. Lee is the Medical Director of UNC Lineberger Clinical Protocol Office which oversees the clinical operations, regulatory affairs, compliance and training, pre-award finance and data management for all therapeutic treatment clinical trials run out of UNC Lineberger.
In this role she provides medical direction and is responsible for ensuring the quality of services provided by the CPO. She has extensive experience as a clinical trial investigator and is knowledgeable of all CPO processes and procedures.
Theresa (Tess) Cummings, RN, DBA
CCRC Director, UNC Lineberger Clinical Protocol Office
Dr. Cummings is the Director of the UNC Lineberger Clinical Protocol Office which oversees the daily activities of Clinical Operations, Pre-Award Finance, Regulatory Affairs, Compliance, Multicenter Operations, Network Operations, and In-House Monitoring.
She is a seasoned clinical research professional having gained experience from her roles at multiple academic institutions and pharmaceutical industry.
CPO Functional Group Leadership
Clinical Operations supports Investigators to enroll patients to phase I-III, adult oncology, clinical research studies. The majority of CPO managed studies involve investigational drugs and/or devices and are regulated by the Food and Drug Administration.
The office is divided into disease teams and comprised of Study Coordinators and Data Coordinators who are responsible for the daily coordination of study visits, collection of source documentation, and data entry as outlined by the research protocol. Professional growth is provided to clinical staff by an established career ladder consisting of Study Coordinator levels 1, 2, and 3/Lead Study Coordinator.
Assistant Director of Clinical Research & Network Operations
Clinical Research Manager: Breast, Gastrointestinal Oncology, Leukemia, Lymphoma, Multiple Myeloma
Clinical Research Manager: Gynecologic Oncology, Head & Neck, Lung, Melanoma, Neuro-Oncology, Phase I, Radiation Oncology, SWAT Resourcing, Urologic Oncology
BSN, RN, OCN, CCRC
Clinical Research Manager: Head & Neck, Lung, Leukemia, Lymphoma, Multiple Myeloma
Regulatory Affairs and Compliance
Regulatory Affairs supports Investigators to maintain their compliance with Institutional and Federal regulations and ICH GCP guidelines. All regulatory activities are maintained including but not limited to study activation, consent writing, continuing reviews, regulatory document and regulatory binder maintenance, training, and compliance activities. Each disease team is supported by a Regulatory Associate and Regulatory Assistant staff member who are integral to the success of each research study.
Assistant Director of Regulatory Affairs and Compliance
The pre-award finance team is responsible for establishing the necessary systems early in the clinical trial activation process to allow for adequate budgeting and contracting. They also work to ensure compliance with the healthcare billing systems.
Pre-Award Clinical Trials Systems Manager
Pre-Award Clinical Trials Manager
The multicenter team is responsible for the operationalization and oversight of multicenter clinical trials. These are clinical trials for which UNC Lineberger serves as the sponsor and are conducted at other clinical trial sites outside of the UNC system. Furthermore, multicenter operations oversees the in-house monitoring of all investigator-initiated treatment trials and cooperative group treatment trials conducted by UNC Lineberger.
Assistant Director of Multicenter Clinical Trials Operations
A centralized structure designed to support Lineberger Clinical Research in a variety of ways including but not limited to new employee orientation, facilities, equipment and space management, recruitment and interviews, talent development, and managing our student internship program.
Additional UNC Lineberger Clinical Trial Leadership
Tracey Conrad, CPA, MHA, UNC Lineberger Associate Director of Finance Administration
Tracey oversees finance administration for UNC Lineberger’s Finance Office. This office is responsible for all post-award financial affairs including sponsor invoicing, patient reimbursement processing, hospital research billing compliance and management of grant awards.
J. Kaitlin Morrison, PhD, Director of UNC Lineberger Sponsored Clinical Research
Dr. Morrison leads the UNC Lineberger Sponsored Clinical Research team that supports the regulatory strategy and translation of basic and translational findings and discoveries at UNC Lineberger and other UNC Centers and Departments working in cancer biology, into early phase clinical trials. She also is responsible for the oversight of UNC Lineberger’s clinical development program that includes investigator-initiated trials using investigational drugs/biologics provided by pharmaceutical partners, and UNC developed and/or manufactured investigational products. Dr. Morrison collaborates with preclinical and clinical scientists to aid in the translation of UNC developed investigational products from the bench to the clinic through the authoring of clinical protocols, informed consent forms, patient education materials, Investigator’s Brochures and Investigational New Drug (IND) applications.
Sai Balu, Facility Director for the Bioinformatics Core at UNC Lineberger
Sai oversees the UNC Lineberger Bioinformatics Core whose mission is to provide infrastructure and analytical expertise to support cancer research for management and analysis of large scale projects as well as promoting individual research to tap the ever-growing data generated by new cancer research topics. Sai leads the Clinical Trial Data Operations team who is tasked with electronic case report form (eCRF) generation, clinical data management, clinicaltrials.gov reporting and electronic data reporting to the FDA.
Victoria Bae-Jump, MD, PhD, Medical Director Office of Clinical and Translational Research
The Office of Clinical and Translational Research (OCTR) supports the translational and correlative research efforts of UNC Lineberger investigators by providing infrastructure, services and training to enable a broad range of local and multi-site research initiatives. The OCTR specializes in the management of tissue and blood-based research with the goal of developing a better understanding of cancer and how to improve the lives of those living with it.