Our leaders drive cutting-edge research and operational success
Our leaders are both dynamic and experts in the field. They drive the CTO’s mission of “Extraordinary Research. Exceptional Care.”
They have a clear vision of a future where patients have more treatment options, better supportive care, and reduced cancer incidence. They have a clear vision of all patients contributing to cancer care of the future by contributing translational sciences and health services research. They aim to make this vision a reality by setting goals and motivating an innovative team to open cutting-edge clinical trials and maximize enrollment of diverse patient populations.
Our leaders guide the operationalization of a portfolio of more than 500 clinical trials led by more than 220 individuals.
“The scientific advances driving the era of personalized cancer medicine are tremendous, but we need to take an equally intense look at the clinical trial processes and operations that will facilitate enrollment of patients on the innovative trials that will bring these new treatments from bench to bedside.”
— Carrie Lee, MD, MPH, Clinical Trials Office Chief Medical Officer
Our leaders are recognized in the field for their success
Our leaders are recognized experts in the field developing novel solutions to better operationalize clinical research including bringing these new treatments from the bench to bedside.
Executive Director, UNC Lineberger Clinical Research J. Kaitlin Morrison, PhD: Presents at the National Academies of Sciences, Engineering, and Medicine Workshop on Training the Regenerative Medicine Workforce for the Future (2022).
Chief Medical Officer, UNC Lineberger Clinical Research Carrie Lee, MD, MPH: Appointed Chair of the Association of American Cancer Institute’s (AACI) Clinical Research Initiative (CRI) Steering Committee (2017-2019). AACI established the Clinical Research Initiative over 10 years ago to develop better methods to disseminate information across cancer centers, identify and address clinical research challenges, and measure progress. Previously Dr. Lee served on the AACI CRI Steering Committee from 2016-2017. Currently Dr. Lee serves as a member of the AACI Physician Clinical Leadership Initiative (PCLI) Steering Committee.
Carrie Lee, MD, MPH: First-authored a manuscript in the Journal of Clinical Oncology (JCO) Oncology Practice: “Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers” (PMID: 33186085). This publication was the first publicly available benchmark data set to characterize the size, cost, volume and efficiency of cancer clinical trial offices used to support the investigation of cancer prevention, early detection and treatment at cancer centers across North America.
J. Kaitlin Morrison, PhD: Currently serves on the External Advisory Committee for the Master of Professional Science (MPS) in Regulatory Science Degree Program at the UNC Eshelman School of Pharmacy. This program is designed to develop future leaders and innovators in pharmaceutical sciences.
Our leaders have served as external advisors to other cancer center’s clinical trials offices
Our staff & leaders serve as invited speakers at national meetings and events
Some examples of their recent presentations include:
For the last nine years, our leaders have been invited speakers at AACI Clinical Research Initiative and/or Cancer Center Administrators Forum including but not limited to:
- Carrie Lee, MD, MPH, “Training, Career Development and Staff Retention Breakout Session” (2023)
- Assistant Director, Regulatory Operations Shaw Scott, JD; J. Kaitlin Morrison, PhD, “Regulatory Breakout Session” (2023)
- Carrie Lee, MD, MPH, “Completing the NCI Cancer Center Support Grant and Meeting New Expectations” (2020)
American Association for Cancer Research Annual Meeting (2023) Carrie Lee, MD, MPH, presented on “Project Site Selector: Navigating Oncology Drug Development Through Troubled Waters.”
Onsemble (2023) OnCore Administrator Jill Frank, MS “Leveraging Advarra University Training.”
2nd Annual Investigator Initiated Trial Summit (2022): J. Kaitlin Morrison, PhD, presented on “Define the Roles of the Company and Investigator in Externally Sponsored Research.”
2nd Annual Investigator Initiated Trial Summit (2022): Clinical Protocol Development Associate Leila Kiefer, PhD, presented on “Site Perspective: Approaches for Successful IIT Development.”
MAGI- Clinical Research Conference (2022): J. Kaitlin Morrison, PhD, presented on “The “Tiny” Details that Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments.”
Association of Clinical Research Professionals (ACRP) Webinar Series (2022): J. Kaitlin Morrison, PhD presented on “Everything You Need to Know about Holding an IND.”
Our leaders present their accomplishments at national meetings
For the last eight years, our staff and leaders have presented poster presentations at AACI Clinical Research Initiative with some highlights including:
- “The Great Rebound: Successful Clinical Trials Office (CTO) Staffing Recovery Strategies” (2023). J. Kaitlin Morrison, PhD, Stephanie Ladd, CCRP (Assistant Director, Clinical Operations), Jessica Huamani-Bundy, MS, CCRP (Director, Sponsor Operations), Chris Hilliard, CCRP (Assistant Director, Clinical Operations), Leslie Schreiner (Office Manager), Nicole Whitman, CCRP (Regulatory Manager), Michael Roxas, MPH (Regulatory Manager), Shaw Scott, JD, Blair Adams, MS, CCRP (Clinical Research Manager), Erica Moore, BSN, RN, OCN, CCRC (Clinical Research Manager), Julianna Maccarone, MPH, MA, CCRP (Scientific Research Manager), Erin Kelly, MPH, RD, LPN (Scientific Research Manager), Jamie Mayfield, MA (Regulatory Manager), Megan Laffan, MA, CCRP (Clinical Research Manager), Coleman Tew, MPA (Director, Clinical Trial Activation), Pavita Derebail, JD (Pre-Award Finance Manager), Leila Kiefer, PhD, Victoria Bae-Jump, MD (Medical Director, Clinical Operations), Carrie Lee, MD, MPH
- “Taking Data Validation to the Next Level: Automating Data Validation using CDASH-Standardized Global eCRFs” (2023). Shreya Rachuri, MSc (SDTM Programmer), Mary O’Dwyer, MRP, CCRP (Assistant Director, Clinical Trials Systems & Reporting), Kathe Douglas (Clinical Data Management Associate), Leilani Logan, MSc (eCRF Developer), Saianand Balu, MS (Facility Director, Bioinformatics Core), Carrie Lee, MD, MPH, J. Kaitlin Morrison, PhD, Erin Crecelius, MA (Assistant Director, Clinical Data Management & Standards)
- “Addressing the Clinical Research Staffing Shortage: Clinical Development ImPACT Internship” (2023). Nasrin Babadi, PhD, RAC (IND Specialist), Leila Kiefer, PhD, Allison Camp, PhD (Clinical Development Associate), Michael Roxas, MPH
- “The Importance of a Dedicated Clinical Trainer in the Hybrid Environment” (2023). Crissey Tait, MPH (Clinical Trainer), Stephanie Ladd, CCRP, J. Kaitlin Morrison, PhD, Diana Wallack, CCRC (SWAT Study Coordinator)