LAUREN BRODERICK
Austin,TX
Summary
Results-driven clinical research professional with 16 years of experience in the pharmaceutical industry, including 15 years within Clinical Research Organizations (CROs). Proven expertise in clinical trial monitoring, vendor oversight, and site relationship management. Adept at ensuring high-quality performance, compliance, and adherence to ethical standards. Strong leadership capabilities with a track record of optimizing site engagement, performance metrics, and monitoring strategies.
Overview
13
13
years of professional experience
Work History
Senior Clinical Trials Manager / Site Care Partner
Syneos Health
Austin, TX
12.2021 - Current
- Serve as the primary sponsor contact for investigative sites, ensuring site engagement, quality standards, and patient safety.
- Oversee site monitoring operations, ensuring adherence to study timelines and performance KPIs.
- Drive site activation, enrollment strategies, and execution of study start-up activities.
- Monitor and assess CRA performance, addressing competency gaps and ensuring training alignment.
- Collaborate with internal teams and vendor managers to optimize resource allocation and trial execution.
- Mentor and train incoming Site Care Partners and Monitors in the Vaccines Business Unit.
Senior Clinical Research Associate
Premier Research
Austin, TX
07.2021 - 11.2021
- Conducted comprehensive site monitoring visits, ensuring compliance with protocol and regulatory requirements.
- Managed study start-up, activation, maintenance, and close-out processes for assigned sites.
- Assessed essential documents and site readiness for activation.
- Provided real-time support and guidance to sites for enrollment and protocol adherence.
Senior Clinical Research Associate
PPD Inc.
Austin, TX
06.2017 - 06.2021
- Led mentorship programs for junior CRAs, acting as a field accompanier for visit sign-off and competency evaluation.
- Assisted Clinical Team Managers in study start-up, regulatory documentation, and UAT testing.
- Conducted monitoring visits, site audits, and ensured timely data entry and issue resolution.
- Provided recruitment and retention support to optimize patient enrollment and study timelines.
Clinical Research Associate II / Central Monitoring Associate II / Project Specialist II
INC Research, LLC.
Austin, TX
07.2012 - 06.2017
- Served as primary site contact, ensuring study protocol adherence and regulatory compliance.
- Conducted site visits, risk assessments, and data monitoring activities.
- Managed study documentation, IRB submissions, and vendor data tracking.
Education
Bachelor of Arts - Psychology
St. Edward's University
Austin, TX08.2008
Skills
- Clinical Trial Oversight & Vendor Management
- Risk-Based Monitoring & Performance Metrics
- Site Activation & Patient Enrollment Strategies
- CRA Performance Monitoring & Training
- Regulatory Compliance (ICH/GCP, FDA)
- Data Integrity & Issue Resolution
- Cross-Functional Collaboration & Stakeholder Communication
- Clinical Operations & Study Execution
Timeline
Senior Clinical Trials Manager / Site Care Partner
Syneos Health
12.2021 - Current
Senior Clinical Research Associate
Premier Research
07.2021 - 11.2021
Senior Clinical Research Associate
PPD Inc.
06.2017 - 06.2021
Clinical Research Associate II / Central Monitoring Associate II / Project Specialist II
INC Research, LLC.
07.2012 - 06.2017
Bachelor of Arts - Psychology
St. Edward's University