Hailey Borst
Charlotte,NC
Overview
5
5
years of professional experience
Work History
Clinical Trials Associate Team Lead
Worldwide Clinical Trials
Charlotte, NC, USA
05.2023 - Current
- Support all aspects of line management supervision to Clinical Trials Associate staff, including, but not limited to, performance management (quality, quantity and timeliness of work performed), coaching and training of staff to enhance and develop skills, guidance on corporate policy and support
- Ensure staff are working to the assigned hours on the project level and meeting utilization requirements at the company level
- Promote a strong team approach to ensure project alignment through active collaboration and communication with Project Management and other departments
- Interview and assist with the selection of new members of staff
- Arrange and track system access for project team (Project Managers, Lead CRAs, CRAs, etc.)
- Maintain and quality audit to ensure the most recent revisions of documents are on project portals
- Assist project team with preparation and shipment of clinical trial documentation, including Investigator Site File
- Maintain version and quality control of project documentation and submit to trial master file
- Assist with the tracking and maintenance of project related information, including site medical question and answer log
- Generate and distribute minutes for a range of project-related meetings, including Sponsor and Internal Management
- Maintain current participating site and personnel information
- Arrange and track the distribution of project specific training to the project team
- Participate in special and complex projects to continuously improve processes, tools, systems, and organization
- Perform other duties as assigned
- Please see the table on Page 3 and 4 for additional Project Management Experience
Clinical Trials Associate
Worldwide Clinical Trials
Charlotte, NC, USA
02.2022 - 04.2023
- Arranged and tracked system access for project team (Project Managers, Lead CRAs, CRAs, etc.)
- Maintained and quality audited to assure the most recent revisions of documents were on project portals
- Assisted project team with preparation and shipment of clinical trial documentation, including Investigator Site File
- Maintained version and quality control of project documentation and submitted to trial master file
- Assisted with the tracking and maintenance of project related information, including site medical question and answer log
- Generated and distributed minutes for a range of project related meetings, including Sponsor and Internal Management
- Maintained current participating site and personnel information
- Arranged and tracked the distribution of project specific training to the project team
Clinical and TMF Operations Associate
TG Therapeutics, Inc.
Raleigh, NC, USA
11.2021 - 01.2022
- Performed Regulatory Start-up, Maintenance, and Closeout activities according to applicable regulations, SOPs, and guidelines
- Served as site/CRO regulatory contact and provide regulatory-related study updates to CRAs or trial project teams
- Prepared site regulatory documents and packets, essential document QC for completeness and accuracy, and monitored site level study activities to ensure regulatory compliance and provide recommendations as needed
- Prepared and submitted central IRB documentation and provided support to central and local IRB/ECs during reviews
Women's Health and Genetics Genomics Sequencing Technologist
LabCorp
Research Triangle Park, NC, USA
03.2021 - 11.2021
- Performed PCR based genomic testing in accordance with standard operating procedures for the diagnosis and treatment of various genetic conditions, including cancer
- Utilized a wide array of instrumentation, including Tecan, ABI 3730, ABI QuantStudio, and Illumina HiSEQ/MiSEQ instruments, performing quality control and calibrations, as required
COVID-19 Laboratory Operations Technologist
LabCorp
Research Triangle Park, NC, USA
06.2020 - 03.2021
- Performed PCR based COVID-19 testing and investigated problem specimens to meet company turn-around-time protocol
- Oversaw sample testing and turn-around-time from the time of collection to analysis and destruction
- Trained a team of employees to troubleshoot and quickly report results for over 50,000 specimens daily
- Authored Standard Operating Procedure Documents for all COVID-19 technical employees to implement
Education
Bachelor of Science - Chemistry, Minor, Biology and Chemical Physics
Meredith College
Raleigh, NC01.2019
Skills
- Phases: I-IV
- Therapeutic Areas:
- Major Depressive Disorder
- Cannabis Use Disorder
- Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis
- Dementia with Lewy Bodies (DLB)
- Head And Neck Cancer Squamous Cell Carcinoma
- Advanced/Metastatic Solid Tumors
LANGUAGE SKILLS
Language(s) Knowledge
English Native
Project Management Training
- Project Plan Review and Updates:
- Authoring first draft of PMVMP
- Authoring first draft of QMD List
- Tracking and ensuring plan updates are completed by due date
- Project Team Meetings:
- Updating and reviewing agendas for all functional areas prior to each meeting, ensuring agenda includes up to date topics for discussion
- Ensuring agenda includes updated metrics
- Leading calls when GPL is unavailable and reviewing updates by function
- Financial Oversight:
- Familiarity with Certinia and Concur for Expense Reports
- Monthly Reporting:
- Shadowed Executive Summary Reports drafting
- Shadowed monthly KPI completion
- Experience shadowing additional meetings such as:
- Monthly Project Review Meetings
- High Value Summary Calls
- Study Meetings: PPR Calls, Vendor Calls, Site Management Calls, TMF Calls, PD Calls, Risk Calls, Site Activation Calls
- Sciforma:
- Reviewing how hours are added and adjusted
- Site Activation / Initiation Readiness:
- Assisting the GPL and CTM in tracking SIV readiness at sites
- Action Item Management:
- Maintaining AI log and follow up with team members as needed
- Updating ADI log during/after each internal and client call
- Trial Master File (TMF) Oversight:
- Reviewing and updating Annotated TMF Structure for multiple functional areas
- Reviewing and updating Trial Master File Management Plan
- Working with functional areas to provide necessary documents
- Supporting GPL with QC metrics oversight
- Provided TMF training to multiple functional areas to demonstrate TMF filing and naming practices
- Independent Project Management Training Courses Completed:
- Worldwide Learning Center:
- ICH GCP Essentials
- Elements of GCP - ICH E8
- Elements of GCP - ICH E6 R3
- Science Media:
- Informed Consent
- GCP Clinical Trial Monitoring
- Drug Development Overview
- Clinical Trial Design
- Protocol, IB and SAP Review
Awards
2025 Deciphera-Worldwide Pathfinder Award Nominee
Timeline
Clinical Trials Associate Team Lead
Worldwide Clinical Trials
05.2023 - Current
Clinical Trials Associate
Worldwide Clinical Trials
02.2022 - 04.2023
Clinical and TMF Operations Associate
TG Therapeutics, Inc.
11.2021 - 01.2022
Women's Health and Genetics Genomics Sequencing Technologist
LabCorp
03.2021 - 11.2021
COVID-19 Laboratory Operations Technologist
LabCorp
06.2020 - 03.2021
Bachelor of Science - Chemistry, Minor, Biology and Chemical Physics
Meredith College