Lauren Bailey Lea
Hampstead,NC
Summary
Results-driven Clinical Trial Coordinator with proven success in supporting audit readiness across five trials for three Sponsors in diverse therapeutic areas. Committed to exceeding Sponsor expectations through effective data stewardship and timely project execution from study activation to closeout. Strong analytical, organizational, and interpersonal skills contribute to the success of fast paced, high-enrollment studies. Highly motivated and adaptable, with a focus on continuous professional growth.
Overview
20
20
years of professional experience
Work History
Clinical Trial Coordinator II
PPD, a part of Thermo Fisher Scientic
Wilmington, NC
04.2023 - Current
- Provide system support (Activate, CTMS, Vault Clinical and client eTMF) and document filing and tracking guidance to the study team
- Organize, facilitate sessions, capture detailed notes, and track progress on assigned tasks.
- Ensure allocated tasks are performed on time, within budget and to a high quality standard
- Coordinate, compile, and distribute electronic Investigator Site Files.
- Maintain knowledge of SOPs, directives, and current regulatory guidelines.
- Prepare and analyze study metrics for accuracy, thoroughness, and punctuality.
- Identify and elevate study risks, determine the root cause, provide action plans, potential process improvements, and system enhancements.
- Provide, delegate, and review CTC study team assignments in relation to goals, study metrics, client requests, and fluctuating volume.
Clinical Trial Coordinator
PPD
Wilmington, NC
01.2022 - 04.2023
- Processed documents in the client eTMF, and performed eTMF reviews within sponsor-specific timelines.
- Analyzed CTMS finding reports using Preclarus, and assisted with the clarification and resolution of findings related to site documentation.
- Reviewed, filed, and tracked site, country, and study IRB/IEC regulatory documents.
- Created a study OneNote regarding client eTMF document classifications, document tracking in CTMS, and process How-Tos to ensure consistency across the study.
- Communicated with the study team (PMs, STMs, CTMs, CRAs, PSCs, and ACRAs) to obtain necessary documents and ensure the prompt resolution of study issues.
- Led training sessions for new CTCs related to processes, systems, and study and sponsor overviews.
Business Owner
Southern Charm Concierge
Hampstead, NC
06.2018 - 12.2021
- Managed day-to-day business operations including accounting, record keeping, taxes, strategic planning, marketing and customer communication.
- Performed in-depth marketing analysis to uncover market trends and determine optimal client segments.
- Cultivated lucrative relationships with new and existing clients through effective communication and exceptional services.
- Designed and launched a client referral campaign to enhance client acquisition.
- Efficiently accomplished business goals by prioritizing and organizing daily tasks.
Exceptions and Analysis Manager
Castle Branch
Wilmington, N.C.
07.2011 - 05.2013
- Elevated quality and decreased turnaround duration to improve client satisfaction.
- Acquired comprehensive knowledge of judicial and criminal terminology.
- Developed the job knowledge of senior staff members.
- Initiated an account assessment and account monitoring process for ranked accounts at risk.
- Took ownership of result discrepancy communication with clients.
- Ensured all information was accurately reported according to industry guidelines and regulations.
Order Fulfillment Manager
Castle Branch
Wilmington, N.C.
03.2011 - 07.2011
- Recruited, trained, coached, and mentored operation employees.
- Worked with other departments to ensure knowledge of operational processes and products.
- Oversaw operational processes and technical enhancements.
- Contributed to designated projects from management.
- Processed employee production numbers and quality by analyzing, merging reports, and compiling information.
Operations Manager
Castle Branch
Wilmington, N.C
06.2007 - 03.2011
- Delegated workload based on fluctuating seasonal volume (MBWA).
- Supervised workforce comprising 30 to 40 individuals.
- Liaison for Sales, Marketing, and Customer Service regarding background check information and processes.
- Conducted annual employee reviews.
- Oversaw staff attendance and ensured adherence to company policies.
- Monitored annual departmental budget.
- Recruited, trained, coached, and mentored operation employees.
Data Import Manager
Castle Branch
Wilmington, NC
02.2006 - 06.2007
- Helped initiate a data entry quality control program to assist in achieving expectations and standards.
- Organized daily work schedules for a team of fifteen.
- Aided in retaining high-value, customized clients through Top 500 initiative.
- Oversaw night-shift operations and managed building closure.
Education
Bachelor of Science - Management
University of North Carolina At Wilmington
05.2007
Skills
- team leadership
- attention to detail
- data management
- risk management/risk escalation
- recruiting
- research and analytical thinking
- project planning
- communication
- proficient in Microsoft Word, One Note, Teams, Excel, Power Point, Outlook and Quickbooks
- trial oversight
- Good Clinical Practice
- Preclarus
- Siebel Clinical Trial Management System (CTMS)
- Advarra
- goBalto Activate
- Veeva Vault - eTMF
- Vault Clinical
Leadership Seminars
- Conflict Resolution, March 2012
- Employee Engagement 101, September 2012
- How to Boost Morale Through Communication, August 2011
- Breaking Bad Communication Habits, August 2011
- Communication and Employee Morale, August 2011
- Developing Trust and Respect in the Workplace, June 2011
- Leadership Training, November 2010
- Sexual Harassment Training, September 2009
- Exceeding Customer Expectations, November 2007
- Taking the Customer Experience and Loyalty to a New Level, October 2007
- Conflict Resolution Skills for Small Businesses, September 2007
Timeline
Clinical Trial Coordinator II
PPD, a part of Thermo Fisher Scientic
04.2023 - Current
Clinical Trial Coordinator
PPD
01.2022 - 04.2023
Business Owner
Southern Charm Concierge
06.2018 - 12.2021
Exceptions and Analysis Manager
Castle Branch
07.2011 - 05.2013
Order Fulfillment Manager
Castle Branch
03.2011 - 07.2011
Operations Manager
Castle Branch
06.2007 - 03.2011
Data Import Manager
Castle Branch
02.2006 - 06.2007
Bachelor of Science - Management
University of North Carolina At Wilmington