Laura Moore
Winter Haven,USA
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
21
21
years of professional experience
Work History
Senior Clinical Trial Associate
Shanton Pharma USA
10.2021 - 09.2022
- Supported US clinical operations in coordination and administration of the study activities
- Collected and mediated approval of vendor contracts and work orders
- Drive study feasibility, start-up, conduct, and closeout in partnership with CRO
- Reviewed/approved study plans and regulatory documents
- Managed/oversee collecting, tracking, archiving, and auditing of essential documents through the life of the study
- Oversight of CRO’s management of the eTMF, CTMS, and other internal systems
- Tracked CRO deliverables including study recruitment and enrollment
- Met high quality ICH, GCP and local regulation standards
- Maintained SharePoint and internal project trackers
- Supported/reviewed study invoice and task/change order
- Supported ancillary site supply management as needed
- Participated in global weekly meetings.
Study Startup Project Delivery Lead, North America
SYNEOS Health
11.2019 - 10.2020
- Responsible for advancing study start-up and regulatory activities by understanding the client objectives and assisted in the development of the plan for country and site activation in North America
- Performed regulatory start up and maintenance function, including the preparation, review, and overall management of submissions to regulatory authorities and ethics committees
- Lead site activation forecasting/projection activities with the input of the local associates
- Administered site activation for assigned projects according to timelines and quality standards
- Served as a contact point for client matters related to study start-up/product approval requirements and communicated issues effectively to the clients and clinical team and Project Manager
- Led day to day project activities for a team of start-up and contract specialists
- Developed training materials/manuals for specific study training and use of related internal and external systems
- Liaised with other project team members to ensure cohesive and clear project performance and expectation
- Assisted clinical monitors to support interactions between medical affairs and site
- Identified site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues
- Escalated risks (e.g., timelines, etc.) as appropriate
- Conducted periodic quality control of entries in the internal systems, databases, and tracking tools
- Prepared weekly reports for internal and external meetings
- Provided recommendations for quality assurance and process improvements
- Maintained required internal and external training
Senior Clinical Site Manager/Senior Clinical Trial Specialist
UBC
08.2006 - 10.2019
- Responsible for leadership in site management, training, and development, and providing overall support for project(s) as directed by Project Management
- Working knowledge of protocol(s), processes, and requirements for assigned project(s)
- Built and managed working relationship with assigned investigative sites (50 plus sites per assigned study) while providing site management activities according to applicable regulations, SOPs, and work instructions
- Provided site activation forecasting/projections to internal and external teams
- Prepared and distributed completed start up package to sites and internal project team members
- Reviewed, tracked, and followed up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Informed team members of completion of regulatory and contractual documents for individual sites
- Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process
- Submitted CTAs to Regulatory Authorities and Central IRB/EC including but not limited to communication with regulatory authorities and/or central ethics committees regarding submission strategy and follow up on ongoing submissions under review
- Ensured accurate completion and maintenance of internal systems, databases, and tracking tools with project specific information
- Reviewed and provided feedback to management on site performance metrics
- Reviewed, established, and agreed on project planning and project timelines
- Ensured monitoring measures are in place and implemented contingency plan as needed
- Provided local expertise during initial and on-going project timeline planning
- Performed quality control of documents provided by sites
- Assisted with preparation and distribution of study binders including electronic folders
- Assisted in data queries
- Performed remote visits (Qualification, Site Initiation, Monitoring, Closeout) Processed site invoices
- Made recommendations for improvement to Project Manager and UBC Management
- For non-monitored studies, responsible for training site personnel and/or ensuring site personnel complete required training (i.e., web-based, Investigator Meeting, etc.)
Project Associate
UBC
01.2007 - 01.2010
- Provided project level administrative support to the Executive and Project Management team
- Assisted with preparation of study procedure manuals
- Assisted with preparation and distribution of study binders
- Created meeting agendas and take action items as needed
- Entered data into spreadsheet templates or other software applications
- Filed project documents
- Conducted periodic quality control of project files
- Assisted with collection of data toward creation of investigator payments
- Arranged project team meetings/teleconferences.
In-House Clinical Research Associate
UBC
01.2006 - 01.2007
- Assisted in the project team in the management of clinical trials according to project and company-specific SOP’s and guidelines
- Responsible for pre-study visits, site initiation visits, site startup, maintenance, remote monitoring visits, and closeout activities such as final document collections and final invoicing
- Corresponded with sites to boost enrollment
- Conducted remote site training on protocol and study procedures
- Contacted sites weekly to provide management and support
- Collected regulatory documents and resolved all data queries
- Reviewed CRF’s for completeness and accuracy
- Interfaced with the data management department
- Ensured the satisfactory completion of documentation and turnaround time for response to serious adverse events.
Data Coordinator
Quintiles
06.2005 - 02.2006
- Performed manual updates in the system that result from data reviews, cleanup campaigns, and periodic monitoring activities
- Run periodic reports as needed and take appropriate actions to clean/modify identified data issues
- Monitored and resolved data discrepancies that impact automated provisioning process.
Assistant Project Manager/Data Manager
Bio-Imaging Technologies, Inc.
10.2001 - 09.2004
- Assisted Project Managers and responsible for project reporting of X-Ray and DXA data
- Responsible for data coordinator work allocations.
IT Project Manager/Architect Systems, Inc.
Architect Systems
10.2003 - 04.2004
- Built and managed working relationship with assigned client
- Responsible for collecting specifications for client sales dashboard.
Education
MBA- Healthcare Management -
University of Phoenix
Kansas City, MO12.2011
BS Human Ecology/Human and Child Development -
University of the Philippines
Los Banos, Laguna12.1992
Skills
- Applications of Microsoft Programs
- Electronic TMF
- CTMS
- Regulatory Submissions
- Informed consent
- Remote Site monitoring
- Electronic Data Capture
- Data Queries
- Clinical Trial Agreements
- Ethics Committee Submissions
- Site Initiation Visits
- Site feasibility Assessments
Non Clinical Employment History
- 2004-06-01, 2005-05-31, Princeton University, Princeton, NJ, Administrative Assistant to the Dean of Faculty (Contract), Provided appropriate assistance and office support to the Dean of Faculty Processed incoming faculty deans., Maintained all correspondence from the Dean of Faculty., Interacted with students on an extensive scale, including addressing student concerns and questions, or complaints., Maintained the calendar of the Dean of Faculty., Assisted the Dean in coordinating and maintaining the various budgets under the Dean's authority – including the Faculty Research Fund, International Conference Travel Fund, and reminders and followers, maintaining file reports., Coordinated and monitored the progress of faculty search processes, including correspondence with potential faculty candidates., Assisted in planning and scheduling of faculty orientation and reorientation, as well as other faculty development activities., Arranged transportation and hotel accommodation as required by the Dean or the Dean's guests.
- 1996-10-01, 2001-09-30, KinderCare Learning Centers, Richboro, PA, Director at KinderCare Learning Center, Richboro, PA (1996-2001), Responsible for overall operations of daycare including but not limited to curriculum building, staff recruitment and training, student enrollment, payroll, and payment processing.
Timeline
Senior Clinical Trial Associate
Shanton Pharma USA
10.2021 - 09.2022
Study Startup Project Delivery Lead, North America
SYNEOS Health
11.2019 - 10.2020
Project Associate
UBC
01.2007 - 01.2010
Senior Clinical Site Manager/Senior Clinical Trial Specialist
UBC
08.2006 - 10.2019
In-House Clinical Research Associate
UBC
01.2006 - 01.2007
Data Coordinator
Quintiles
06.2005 - 02.2006
IT Project Manager/Architect Systems, Inc.
Architect Systems
10.2003 - 04.2004
Assistant Project Manager/Data Manager
Bio-Imaging Technologies, Inc.
10.2001 - 09.2004
MBA- Healthcare Management -
University of Phoenix
BS Human Ecology/Human and Child Development -
University of the Philippines
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