Senior Clinical Research Professional
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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.
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.
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
Program Manager/ Lead CRC • Hematologic Malignancies Team •
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
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
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
