Stephanie Ladd

Highly motivated, data-driven Senior Clinical Research Professional with a 12-year track record of clinical operations improvement and strategic planning. Expert in change management, stakeholder collaboration, clinical research operations, process engineering, and mentorship. Dedicated team leader with a focus on performance and project delivery. Excellent attention to detail, organization, problem solving, and communication skills.

Experience

Assistant Director, Clinical Research & Network Operations •

UNC Lineberger Comprehensive Cancer Center

Direct clinical research operations for the UNC Lineberger Clinical Protocol Office; Integrate and expand research operations within the UNC Health system and select network entities; Serve as a key member of the leadership team with a primary focus on management and professional development of clinical research personnel, operational and strategic planning, implementation of policies and systems, clinical trial budget development, and integrated hospital operations.

Key Accomplishments:

• Expanded clinical research operations to UNC Hillsborough │ 2022
• Significantly increased staffing, expanded and reclassified clinical career ladder positions │ 2022
• Integrated LCCC research operations with UNC Rex, jointly activating 6 clinical trials and merging regulatory, pharmacy, financial, data management, and compliance functionality │ 2021
• Successful FDA audit │ 2021
• Navigated UNC SOM Working Forward initiative shifting research operations to a hybrid work model during COVID-19 pandemic │ 2020
• Initiated and led Trial Termination project resulting in close out of 66 trials and redistributing valuable resources │ 2020
• Contributed to successful CCSG grant renewal │ 2019
• Initiated and facilitated Research Billing A3 process improvement │ 2019
• Integrated Clinical Pipe, an innovative software system used to automatically enter data into Sponsor’s case report forms, with Epic EMR │2019
• Successful LAPS grant renewal │2018

Clinical Research Operations Manager • 

UNC Lineberger Comprehensive Cancer Center

Managed daily operations of therapeutic oncology clinical research

• Hired, oriented, trained, and managed clinical staff (20-35 FTEs)

• Allocated resources appropriately using metrics-driven approach

• Fostered employee engagement and retention via implementation of career ladder and supporting professional development

• Enhanced interdisciplinary communication and collaboration between internal and external departments

• Improved quality and conduct of research operations

• Developed and continually refined SOPs, policies, and training curriculum via advanced quality improvement methods

• Tracked activation timelines, prepared financial forecasts, assessed staffing resources, etc. for expeditious protocol activation

Key Accomplishments:

• Successfully integrated Gyn-Onc research program into CPO operations │ 2018
• Optimized Epic EMR for all source documentation, eliminating paper flowsheets │ 2018
• Implemented clinical career ladder │ 2017
• Developed OnCore End-User Training Curriculum │ 2017
• Successful FDA audit │ 2017

Program Manager/ Lead CRC • Hematologic Malignancies Team • 

Yale Cancer Center

Managed the hematologic malignancy research program (80+ trials)

• Directly supervised and trained clinical research nurses, patient schedulers, data management staff, and regulatory coordinators

• Oversaw trial activation, conduct and close out at Smilow Cancer Hospital and 10+ network locations across Connecticut

• Managed competing priorities to meet institutional and sponsor driven deadlines

• Represented the hematologic malignancy team to hospital services, business/budget/contract offices, investigators, industry sponsors, and patients

• Maintained regulatory compliance including all aspects of study activation, IRB renewals and amendments, expedited IRB reporting of SAEs & noncompliance, and Data Safety Monitoring Reports

• Contributed to protocol development

• Coordinated site qualification and initiation visits, internal and external audits

• Led weekly disease team meetings

• Developed and continuously improved SOPs

• NCTN SWOG Site Administrator

Key Accomplishments:

• Highest enrolling team to ETCTN under site PI Pat LaRusso, DO │ 2015
• Contributed to streamlining research charge review process │ 2015
• Implemented non-nurse coordination model │ 2014
• Successful FDA audit │ 2013

Office Manager/ Sr. Administrative Asst. to YCC & YCCI Directors • Yale Cancer Center

Managed CTO staff onboarding and training program

• Developed CTO SOPs

• NCTN SWOG site administrator

• Developed and managed patient recruitment website

• Performed quality control of OnCore CTMS & ensured corrective action

• Provided and validated clinical trial metrics

• Coordinated trial feasibility review meetings

• Managed CTO office space and equipment for four office locations

• Provided high-level administrative support to Cancer Center Directors

• Provided regulatory support as needed

• Managed archiving program

Key Accomplishments:

• Expanded CTO from 1 to 4 office locations
• Assisted in the integration, onboarding, and research portfolio expansion of 8 private oncology practice locations acquired by Yale New Haven Hospital
• Developed patient recruitment website
• Transition and rostering of YCC Investigators & staff to SWOG main membership
• Assisted in OnCore financials implementation & OnCore-Epic Integration

Data Manager • Breast & Melanoma Teams • Yale Cancer Center

Performed data entry for therapeutic trials; maintained and audited study files for accuracy; engaged study teams and investigators in process improvement for data collection at the bedside; Assisted in OnCore site implementation and system validation; OnCore superuser

January 2011 – March 2011

Regulatory Affairs Assistant • via Kelly Scientific • Yale Cancer Center

Regulatory support for therapeutic trials, established standardized binder structure for CTO, maintained essential documents, IND safety reports, personnel amendments, team communication

August 2010 – January 2011

Clinical Research Assistant • Suffolk Obstetrics & Gynecology, Port Jefferson, N.Y 

Coordinated clinical trials and maintained medical records in a private office setting

Bachelors of Science from the University of Central Florida in Molecular and Microbiology