Lisa Gorgone
Gladstone,MO
Summary
With over 30 years of experience in healthcare, including 20 years specializing in clinical research, site activation, contracts, and budgets, I bring a wealth of knowledge to the table. My unique advantage comes from having worked in various roles within the industry, including CRO, Sponsor, and Site perspectives. This has allowed me to optimize start-up processes and understand the intricacies of GCP/ICH, FDA regulations, and Phases I-IV of clinical research. As a leader of study teams, I am skilled at improving efficiency and finding innovative solutions to reduce cycle times. Mentoring and training teams in contract negotiations, regulatory compliance, and study start-up best practices is another area where I excel. My in-depth knowledge ensures accurate and effective guidance, while my critical thinking and problem-solving skills help me address complex challenges. Throughout my career, I have maintained a strong track record of effective communication and collaboration in diverse team settings.
Overview
37
37
years of professional experience
Work History
Contracts Site Activation Lead / Portfolio Subject Matter Expert (cSAL/SME)
ICON PLC
08.2022 - Current
- Lead all site contracting activities for start-up and maintenance across the Sponsor Partnership Portfolio
- Develop study contract and budget templates with Sponsor for each new study
- Train negotiators on study-specific protocols, escalation processes, and risk mitigation strategies
- Manage site contracting processes, wrote the Negotiation Guide (US & ROW) and the Template Build Guide
- Act as the primary point of contact for Sponsor Management, driving contract and budget process improvements
- Developed the Global Contracting Template Repository in Box, ensuring standardization and compliance
- Created 50+ Country Data Sheets consolidating key country contracting intelligence
- Review CTMS weekly for compliance and identify risks to activation timelines
Site Activation Lead
ICON PLC
04.2022 - 08.2022
- Led regulatory and contract teams for assigned studies, ensuring on-time site activation and IP shipment
- Specialized in resolving complex site negotiations, securing successful contract finalization
- Turned around a failing project, leading to 40+ contract executions and earning Sponsor recognition
Clinical Start-Up Associate (CSA) | Start-Up Team Lead & Sr. Site Contract/Budget Specialist
LIGHTSHIP
08.2021 - 04.2022
- Led the start-up process for a high-profile decentralized (DCT) hybrid study, meeting all milestones
- Played a key role in developing Lightship's Master Investigator Agreement and Study-Specific Work Orders
- Served as Lightship's SME for all site contract and budget matters, training and mentoring a team of 4
- Designed and implemented an internal tracking system for study milestones in the absence of a CTMS
- Collaborated with IT on Lightship's Custom CTMS development, contributing to system improvements
Senior Contract Specialist
PPD
11.2019 - 08.2021
- Managed site contract execution for multiple studies, consistently exceeding cycle-time expectations
- Built strong relationships with site personnel, improving contract execution rates
- Executed 12 high-priority contracts ahead of schedule, strengthening Sponsor partnerships
- Received the PPD CEO Defining Principles Award for excellence in site contract management
Clinical Trial Specialist II
UBC LLC
07.2013 - 11.2019
- Managed 200 sites from site selection through activation, maintenance, and close-out over 5 years
- Oversaw regulatory submissions, essential document collection, ICF revisions, and TMF maintenance
- Led a large-scale contract/budget amendment project, ensuring compliance and efficiency
- Served as Acting PM on a high-profile DMD trial, activating all 10 sites ahead of schedule, earning UBC's first Employee Spotlight Award
Contracts Start-Up Specialist
QUINTILES, Inc.
01.2013 - 07.2013
- Reviewed and negotiated site contracts and budgets for assigned sites across multiple protocols
- Led teleconferences with Sponsors and sites to resolve contractual roadblocks and accelerate start-up
Site Start-Up Specialist
QUINTILES, Inc.
08.2007 - 01.2013
- Managed regulatory and contract negotiations to ensure on-time site activation
- Successfully met or exceeded site activation projections across multiple projects
- Worked closely with sites to complete all regulatory and contract documentation requirements
- Collaborated with internal teams to streamline site initiation processes and improve activation timelines
Document Specialist (Contractor)
Takeda Pharmaceuticals
10.2006 - 08.2007
- Performed QC reviews and maintenance of Trial Master Files (TMF), ensuring compliance
- Provided training and system support to clinical teams on electronic document management
Unit Secretary/Monitor Technician/Ward Clerk
Alta Bates Medical Center
01.1988 - 01.1999
- Supervised clerical staff, conducted performance reviews, and managed unit documentation
- Monitored telemetry systems, transcribed physician orders, and coordinated patient care logistics
- Thrived in a high-pressure, fast-paced environment, ensuring efficiency and accuracy
- Assisted nursing staff with patient care, ensuring timely completion of tasks and improved patient satisfaction.
- Supported hospital compliance efforts by adhering to privacy policies and HIPAA regulations when handling sensitive patient information.
- Maintained rapport with physicians, nurses and other healthcare personnel.
- Assisted with the training and onboarding of new unit secretaries, sharing expertise and best practices to ensure their success in the role.
Education
Coursework - Psychology, Sociology, Algebra
MidAmerica Nazarene University
Early Childhood Development -
Oakland
Skills
- Fluent Medical Terminology
- Skilled in Word Processing
- Excel Spreadsheet Management
- Effective Presentation Design
- Email Management Expertise
- Effective Team Leadership
- Clinical Trial Management System
- SharePoint
- Florence
- Box
- Firecrest
- Experience with Veeva Vault
- Activate Proficiency
- Siebel
- Experienced with Medidata RAVE
- InForm
- Coaching and Guidance
- Strong analytical skills
- Innovative Problem-Solving
- Task Organization and Efficiency
- Effective Team Collaboration
- Team building
- Analytical Problem-Solving
Technical Skills - Key Skills
Word, Excel, PowerPoint, Outlook, Teams, CTMS, SharePoint, Florence, Box, Firecrest, Veeva Vault, GoBalto/Activate, Siebel, Medidata RAVE, InForm, and more., Fluent in English, Advanced Medical Terminology
Education And Training - Certifications And Training
- Arrhythmia Interpretation Course, Alta Bates Medical Center - 100% top in class
- Coursework in Psychology, Sociology, and Algebra, MidAmerica Nazarene University
- Early Childhood Development, Oakland, CA
- Extensive GCP, FDA Regulations, and Clinical Research Ethics Training
- CITI Program Certifications - Lightship Inc. (2021), Borgess Research Institute (2006)
- Effective Management & Conflict Resolution Training, Alta Bates Medical Center
Languages
English
Native or Bilingual
Timeline
Contracts Site Activation Lead / Portfolio Subject Matter Expert (cSAL/SME)
ICON PLC
08.2022 - Current
Site Activation Lead
ICON PLC
04.2022 - 08.2022
Clinical Start-Up Associate (CSA) | Start-Up Team Lead & Sr. Site Contract/Budget Specialist
LIGHTSHIP
08.2021 - 04.2022
Senior Contract Specialist
PPD
11.2019 - 08.2021
Clinical Trial Specialist II
UBC LLC
07.2013 - 11.2019
Contracts Start-Up Specialist
QUINTILES, Inc.
01.2013 - 07.2013
Site Start-Up Specialist
QUINTILES, Inc.
08.2007 - 01.2013
Document Specialist (Contractor)
Takeda Pharmaceuticals
10.2006 - 08.2007
Unit Secretary/Monitor Technician/Ward Clerk
Alta Bates Medical Center
01.1988 - 01.1999
Early Childhood Development -
Oakland
Coursework - Psychology, Sociology, Algebra
MidAmerica Nazarene University
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