Jennifer White
Raleigh,North Carolina
Summary
With over 18 years of experience in clinical trial management and project coordination, this detail-oriented clinical research professional excels in driving process improvements and maintaining compliance with ICH-GCP standards. Proven ability to deliver Trial Master Files (TMF) 100% compliant during study closeout activities highlights exceptional quality assurance skills. A collaborative team player adept at managing schedules, coordinating resources, and ensuring high-quality trial documentation while effectively communicating with internal stakeholders and vendors. Career aspirations include leveraging expertise to lead larger, more complex global clinical trials.
Overview
18
18
years of professional experience
Work History
Senior Project Specialist
Syneos Health
Morrisville, NC
10.2014 - 08.2024
- Managed comprehensive project documentation, including the establishment and organization of Trial Master Files, regulatory compliance tracking, and maintenance of key performance indicators and financial reports
- Facilitated the distribution and reconciliation of study-related financial transactions, including site and vendor invoicing and investigator payments
- Coordinated and documented internal and external meetings, ensuring clear communication of minutes and assisted with the follow-up on outstanding action items to ensure timely resolution
- Acted as a primary point of contact for quality assurance processes, contributing to audit preparations, documentation organization, and addressing identified issues to completion
- Provided mentorship and training to novice Project Specialists, enhancing team capabilities and ensuring continuity of project knowledge and practices
- Improved project efficiency by implementing streamlined processes and optimizing resource allocation
- Implemented quality assurance measures to maintain high standards throughout the project lifecycle, resulting in consistently successful outcomes
- Championed continuous improvement initiatives within the organization by sharing best practices learned from past projects experiences
Senior Project Associate
Clintrax Global
Raleigh, NC
01.2014 - 10.2014
- Managed documentation, reports, and databases, while analyzing team metrics to align with sponsor objectives, ensuring operational efficiency and goal attainment
- Developed and updated training materials for Contract and Project Associates, and mentored staff, enhancing team proficiency in TrialCTA and Sales Force
- Streamlined internal processes to increase team productivity and reduce bottlenecks in project workflows
- Consistently met deadlines through proactive planning and diligent follow-up with team members on task progressions
- Verified quality of deliverables and conformance to specifications before submitting to clients
Project Associate III
PRA International (now ICON)
Raleigh, NC
03.2011 - 11.2013
- Managed comprehensive project documentation, ensuring accuracy and timely updates; analyzed team performance data to support the achievement of sponsor objectives
- Developed and enforced team policies and processes, enhancing overall productivity; created training materials to standardize work procedures and improve staff competency
- Coordinated internal and external communications, maintained essential records, and supervised logistical tasks; conducted research and analysis to support project managers and executive leadership
- Streamlined data collection processes by implementing efficient tracking systems, leading to more accurate reporting and analysis capabilities
- Conducted thorough risk assessments to identify potential threats to project success and developed contingency plans accordingly
- Partnered with project team members to identify and quickly address problems
- Tracked project and team member performance closely to quickly intervene in mistakes or delays
In-House Clinical Research Associate
PRA International (now ICON)
Raleigh, NC
05.2006 - 03.2011
- Managed investigative site evaluations using tools such as phone scripts and questionnaires, and maintained accurate documentation through the Clinical Trial Management System, ensuring compliance with regulatory standards
- Conducted feasibility studies and collected essential documents, facilitating the distribution and follow-up of Confidential Disclosure Agreements to expedite site interest and adherence to study timelines
- Assisted in the preparation and submission of regulatory documents to local IRBs/ethics committees, contributing to the maintenance of compliance with local and international guidelines throughout clinical trials
- Streamlined office operations by maintaining comprehensive documentation and managing databases, resulting in enhanced team efficiency and accurate scheduling
- Conducted thorough data compilation and analysis, contributing to informed decision-making and supporting various departmental projects through meticulous research and report preparation
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
- Implemented electronic data capturing systems to adhere with clinical research guidelines
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process
- Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials
- Prepared and maintained regulatory documents for clinical trial submissions
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines
- Assisted in the preparation of regulatory submissions, supporting successful approval for clinical trials
Education
Bachelor of Science - Technical Management
DeVry University
12.2015
Associate of Applied Science - Medical Office Administration
Wake Tech Community College
05.2011
Skills
- Veeva Vault
- ORACLE Siebel CTMS
- Medidata CTMS
- Trial Interactive
- PhlexEView
- Microsoft 365 & TEAMS
- Medidata RAVE
- GoBalto
- SharePoint
- Documentation Management
- Audit Preparation & Quality Assurance
- Risk Management in Clinical Trials
- Regulatory Compliance (ICH-GCP, FDA, IRB)
- Multi-tasking abilities
- Time Management
- Written and Verbal Communication
- Problem-solving
- Attention-to-Detail
- Teamwork and collaboration
- Mentoring and coaching
References
References available upon request.
Timeline
Senior Project Specialist
Syneos Health
10.2014 - 08.2024
Senior Project Associate
Clintrax Global
01.2014 - 10.2014
Project Associate III
PRA International (now ICON)
03.2011 - 11.2013
In-House Clinical Research Associate
PRA International (now ICON)
05.2006 - 03.2011
Bachelor of Science - Technical Management
DeVry University
Associate of Applied Science - Medical Office Administration
Wake Tech Community College
Similar Profiles
Lauren M. Wahl-RiversLauren M. Wahl-Rivers
Clinical Research Associate II at Syneos HealthClinical Research Associate II at Syneos Health
Marshonda WootenMarshonda Wooten
Engagement Center Specialist at Syneos HealthEngagement Center Specialist at Syneos Health
Marie Emmanuelle Koffi KouameMarie Emmanuelle Koffi Kouame
Results Analyst II – Immunology at Syneos HealthResults Analyst II – Immunology at Syneos Health
Tracy ToppTracy Topp
Associate Director, Clinical Trial Management at Syneos HealthAssociate Director, Clinical Trial Management at Syneos Health
Bouchra BoujaadaBouchra Boujaada
Teacher at Ministry Of EducationTeacher at Ministry Of Education