Stephanie Ladd
CCRP
Assistant Director of Clinical Research & Network Operations
Our Leadership
Clinical Trials Office Executive Leadership
Carrie Lee, MD, MPH
Chief Medical Officer, UNC Lineberger Clinical Research
Dr. Lee is the Chief Medical Officer for UNC Lineberger Clinical Research 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.
Carrie Lee
MD, MPH
J. Kaitlin Morrison, PhD
Executive Director, UNC Lineberger Clinical Research
Dr. Morrison is the Executive Director, UNC Lineberger Clinical Research and an Assistant Professor of Medicine in the Division of Hematology. Dr. Morrison is responsible for the leadership and oversight of the UNC Lineberger clinical research infrastructure, and co-leads strategic planning driving clinical research infrastructure optimization, process improvements, recruitment and retention of employees, and alignment of UNC Lineberger and UNC Healthcare system goals. Dr. Morrison supports the regulatory strategy and translation of basic and translational findings and discoveries into early phase clinical trials. She collaborates with preclinical and clinical scientists to aid in the translation of UNC developed investigational products from the bench to the clinic through both clinical development and interactions with regulatory authorities such as the Food and Drug Administration (FDA).
CTO Medical Directors
Victoria Bae-Jump, MD, PhD
Medical Director, Site Operations
Dr. Bae-Jump is a Medical Director of UNC Lineberger’s Clinical Trials Office overseeing its clinical trial site operations. In this role she provides medical direction and is responsible for ensuring the quality of services provided by the CTO. She has extensive experience as a clinical trial investigator for both clinical and translational studies and is knowledgeable of CTO site clinical operations and regulatory processes and procedures. Dr. Bae-Jump also serves as a Board Member on the UNC IRB (OHRE) serving on the Safety and Welfare Analysis Group (SWAG) which reviews potential Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs).
Victoria Bae-Jump
MD, PhD
CTO Functional Group Leadership
Clinical Operations
Clinical Operations supports the Investigators who enroll patients to phase I-III, adult oncology, clinical research studies. The majority of CTO 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.
Blair Adams
MS, CCRP
Clinical Research Manager: Breast, Gastrointestinal Oncology, Leukemia, Lymphoma, Multiple Myeloma
Erica Moore
BSN, RN, OCN, CCRC
Clinical Research Manager: Head & Neck, Lung, Leukemia, Lymphoma, Multiple Myeloma
Regulatory Operations
Regulatory Operations 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.
Shaw Scott
JD
Assistant Director of Regulatory Affairs and Compliance
Michael Roxas
MPH, CCRP
Regulatory Manager
Clinical Trial Activation
The clinical trial activation team includes pre-award finance and project management of clinical trial activation. 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. Activation project managers lead clinical trial activation planning and execution, during which the team schedules activities and project completion dates, leads, coaches, motivates and influences staff completion of activation deliverables, and monitors activation progress.
Coleman Tew
MPA
Pre-Award Clinical Trials Manager
Sponsor Operations
Sponsor operations oversees the conduct of clinical trials at multicenter sites and compliance at both UNC and multicenter sites. Its 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. The sponsor operations team also performs in-house monitoring of all investigator-initiated treatment trials and cooperative group treatment trials conducted by UNC Lineberger. The sponsor operations team also oversees coordination of the Data and Safety Monitoring Committee (DSMC), Protocol Review Committee (PRC), Standard Operating Procedure (SOP) Committee, Compliance Committee, and auditing.
Jessica Huamani-Bundy
MS, CCRC
Assistant Director of Multicenter Clinical Trials Operations
Workforce Development & Administration
The Workforce Development & Administration team supports new employee orientation, facilities, equipment and space management, recruitment and interviews, talent development, and managing our student internship program. They also oversee the onboarding and training programs.
Leslie Schreiner
Office Manager
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.
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.
