Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
18
18
years of professional experience
Work History
Site Management Associate I
Fortrea (Formerly Labcorp)
10.2021 - 05.2024
Ensure compliance with Fortrea SOPs, Project-specific Controlled Documents, FDA and ICH guidelines, GPPs and GCPs for clinical conduct in all aspects of daily work including adherence to Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, etc
Perform site evaluation and recruitment including, collection and review and close out of required critical documents from sites by creating, updating, tracking and maintaining study-specific trial management files, tools and systems
Support investigators in fulfilling their obligations with regard to submission according to applicable local, regulatory and IRB/IEC requirements, from the early stage in the US and after the initial submission in the other countries
Maintain regular contact with study sites via telephone (in-coming and out-going calls), email and newsletters and ensure timely documentation of these contacts in defined project system
Act as primary point of contact for assigned study sites, manage subject screening/enrollment, Data Collection Tool retrieval, study supply and query distribution to/retrieval from assigned study sites and retain primary responsibility for the resolution of all site issues
May assist in development of phone scripts, questionnaires, study site materials and other project specific tools
Manage investigator site budgets
Review study data in accordance with Monitoring Plan, Site Management Plan, Data Management Plans and applicable (SOPs, etc.) to identify data trends, data inconsistencies and erroneous, missing, incomplete, or implausible data through the aggregate review of study data by patient, site and/or project
Ensure accurate and expeditious safety reporting in accordance to federal or local guidelines and sponsor and program requirements
Responsible for all aspects of remote site monitoring activities, including PSV, SIV, routine monitoring and COV.
Assistant Site Management Associate
Fortrea (Formerly Labcorp)
10.2020 - 10.2021
Ensured compliance with Fortrea SOPs, Project-specific Controlled Documents, FDA and ICH guidelines, GCPs and GPPs for clinical conduct in all aspects of daily work including adherence to Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, etc
Assisted with the facilitation of site evaluation and recruitment including, collection, review and close out of required critical documents from sites by creating, updating, tracking and maintaining study-specific trial management files, tools and systems
Supported investigators in fulfilling their obligations with regard to submission according to applicable local, regulatory and IRB/IEC requirements, from the early stage in the US and after the initial submission in the other countries
Maintained regular contact with study sites via telephone (in-coming and out-going calls), email and newsletters and ensured timely documentation of these contacts in defined project system
Acted as primary point of contact for assigned study sites and retained primary responsibility for the resolution of all site issues
Managed subject screening/enrollment, Data Collection Tool retrieval, study supply and query distribution to/retrieval from assigned study sites
Assisted with administrative duties including preparation of status reports, payments to sites and participation in regular project team meetings
Assisted with the review study data in accordance with Monitoring Plan, Site Management Plan, Data Management Plans and applicable (SOPs, etc.) to identify data trends, data inconsistencies and erroneous, missing, incomplete, or implausible data through the aggregate review of study data by patient, site and/or project
Ensured accurate and expeditious safety reporting in accordance to federal or local guidelines, sponsor and program requirements
May have performed remote monitoring visits, such as PSVs, SIVs, RMVs and COVs, as required by the monitoring plan.
Compliance Manager
The Wenger Group
05.2016 - 10.2020
Worked in 3 divisions of The Wenger Group which had included Wenger Feeds, Nutrify and Dutchland Farms
Investigated and resolved customer feed inquiries and complaints in a timely manner
Served as liaison for customers, management and sales team
Provided excellent customer service
Served as subject matter expert by advising staff and customers and worked directly with external agencies throughout audits or to remedy compliance issues
Supported 5 poultry service technicians and their production manager to ensure all contracted flocks met requirements for animal welfare compliance requirements
Educated customers in each division of the company from what type of feed for their flock, available ingredients for purchase and how to become compliant and the regulations in the poultry industry.
Research Associate
DuPont Pioneer
01.2011 - 03.2016
Functional lead of all non-soybean crops growth process across multiple locations
Project management of planting, transplanting and plant health
Previously responsible for data management of trait informatics and analysis results using in-house data base systems, Excel, Spotfire and Filemaker
Experience working with data collection mobile devices, software systems and data networks
Used multiple database management, Excel, Spotfire and Filemaker
Time and task management for self and team
Previous assistant greenhouse grower over multiple greenhouses, greenhouse management including fertigation, irrigation and plant health using PH and EC monitoring
Collected agronomic ratings and organizational data
Previously responsible for protocol writing, process improvement, LEAN system utilization.
Research Assistant
The Pennsylvania State University
09.2009 - 12.2010
Previously responsible for data collection and management
Crop and pesticide application trial research
Used multiple programs for data management including ARM and excel
Assisted with compiling and editing data for the yearly 300+ page Agronomy Guide.
Agronomy Intern
Penn State Extension
05.2008 - 09.2010
Worked side by side with county farmers to address crop production issues such as nutrient deficiency, weed control and general issues
Identified nutrient deficiencies and invasive weeds in crops
Previously responsible for data collection in state soybean sentinel plots across the southeastern area
Organized pesticide credit meetings for farmers
Worked with a team for the Farmer to Farmer program to map no-till and tilled land across Lancaster County
Estimated corn yield with the use of standard deviation across Lebanon County.
Administrative Assistant
Bertz, Hess and Co., LLP
01.2006 - 12.2008
Answered a multi-line telephone and directed clients to the appropriate accountant
Greeted clients professionally in office
Previously responsible for accounts receivable
Filed assembled tax returns
Performed data entry
Worked to meet deadlines under strict time constraints.
Executive Director, Project Finance at FORTREA (formerly Labcorp Drug Development)Executive Director, Project Finance at FORTREA (formerly Labcorp Drug Development)
Associate Manager, Medical Data Review at Fortrea (Formerly Labcorp), BengaluruAssociate Manager, Medical Data Review at Fortrea (Formerly Labcorp), Bengaluru