JULIE STEPHENSON
Thousand Oaks
Summary
Results-driven Clinical Trials Associate with proven success in site monitoring and management. Skilled in regulatory compliance and cross-functional team collaboration, effectively reducing study timelines and ensuring successful trial outcomes.
Overview
36
36
years of professional experience
1
1
Certification
Work History
Clinical Trials Associate/Site Management Associate II
ICON Clinical Research/Vertex Pharmaceuticals
Thousand Oaks
10.2019 - 06.2025
- A Clinical Trials Associate/Site Management Associate II is responsible for supporting and managing clinical trial sites to ensure compliance with protocols, regulations, and company procedures. This role involves a mix of on-site and remote activities, including site initiation, monitoring, and close-out visits, as well as maintaining communication with sites and project teams.
- Good knowledge of clinical research processes and an understanding of Regulatory and Central/Local ethic submission processes for assigned countries; working knowledge of current ICH GCP guidelines and applicable regulations.
- Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.
- Served as a key liaison between investigative sites and study sponsors, ensuring prompt communication of updates, concerns, or requests.
- Managed investigational product inventory levels, ensuring adequate supply for all enrolled patients at each study location.
- Maintained study-related trackers and updating system access user lists.
- Assisted with the preparation, tracking, and maintenance of study documents, including the Trial Master File (TMF).
- Assisted with data collection, verification, and entry into clinical trial management systems (CTMS).
- Ensured compliance with regulatory guidelines, maintaining accurate and up-to-date records throughout all phases of the trial.
- Collected, evaluated, and modeled collected data.
- Followed informed consent processes and maintained records.
Study Project Coordinator/Grants Specialist
ICON Clinical Research/Amgen
Thousand Oaks
04.2013 - 09.2019
- As a Study Project Coordinator/Grants Specialist at Amgen my responsibilities combined project management and grant administration skills to support grant-funded studies and initiatives. This role involves project management and operational support for research initiatives. My responsibilities included developing relationships with internal partners, supporting business needs, developing project plans, facilitating meetings, tracking progress, and finding solutions to improve processes.
- Maintained accurate documentation of all projects, facilitating efficient audits and future references.
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Responded to requests for information on materials to inquiring parties.
- Decreased project completion times by efficiently prioritizing tasks and delegating responsibilities to team members.
- Cultivated strong relationships with key project stakeholders through regular, transparent communication, securing their ongoing support and trust.
Agency Field Support Specialist
State Farm Insurance
Thousand Oaks
06.1989 - 03.2013
- As an Agency Field Support Specialist at State Farm, my position focused on helping agents, thirty-five (35) and their teams succeed by promoting technology adoption, initiatives, and processes to maximize sales opportunities. This role involved providing support, training, and resources to agents, often requiring travel to different locations.
- Delivered detailed reports on equipment performance metrics, enabling informed decision-making regarding future investments in technology upgrades or replacements.
- Served as an effective liaison between clients' needs and internal resources to ensure swift and satisfactory resolution of all technical concerns.
- Supported successful project completion by providing accurate documentation, reporting, and data analysis as required.
- Increased productivity for field teams with efficient coordination, scheduling, and prioritization of service requests.
- Enhanced team performance by sharing knowledge, best practices, and innovative problem-solving techniques with colleagues on a regular basis.
- Contributed to company growth by consistently meeting or exceeding targets related to response times, client satisfaction scores, and closed tickets per month metrics.
- Maintained current industry knowledge through continuous professional development, attending training sessions, workshops, and conferences relevant to the Field Support Specialist role.
Education
Associate of Arts - Liberal Arts and Sciences
Moorpark College
Moorpark, CA05.2004
Skills
- Site monitoring and management
- Clinical trial knowledge
- Team collaboration
- Problem-solving and critical thinking
- Organizational and time management skills
- Multitasking proficiency
- Communication and relationship building
- Data verification and quality assurance
- Adaptability and flexibility
- Regulatory compliance and ethics
Accomplishments
- INSPIRE Award for Innovation and Quality
- Recognized for Extraordinary Contributions and Support to Team Operations
- Award for Excellence in Quality of Work and Deliverables
Certification
- Vertex University - Specialized training including: Good Clinical Practice (GCP), Good Laboratory Practices (GLP), Research Ethics, Adverse Event Reporting, Adverse Event Reporting, Anti-Bribery and Anti-Corruption and Data Privacy and Security.
Timeline
Clinical Trials Associate/Site Management Associate II
ICON Clinical Research/Vertex Pharmaceuticals
10.2019 - 06.2025
Study Project Coordinator/Grants Specialist
ICON Clinical Research/Amgen
04.2013 - 09.2019
Agency Field Support Specialist
State Farm Insurance
06.1989 - 03.2013
Associate of Arts - Liberal Arts and Sciences
Moorpark College
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