About 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
ExperienceNovember 2018 to Present 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:
August 2016 – November 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:
March 2013 – July 2016 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:
October 2011 – March 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:
March 2011 – February 2012 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 |
Education
Bachelors of Science from the University of Central Florida in Molecular and Microbiology
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