Job Search Status
Open to workDesired start date: Immediately
Open To Work
Teresa Rodriguez
Arvada
Work Preference
Summary
Experienced Clinical Research Associate with 26 years in managing phase I-IV clinical trials. Expertise in ICH-GCP guidelines and FDA regulations, ensuring protocol compliance and enhancing patient safety through collaboration with cross-functional teams. Proficient in training staff, managing sponsor relationships, and overseeing clinical sites.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate (Sr. CRA)
Kelly Services
02.2022 - 02.2026
- Oversaw and monitored multiple clinical trials from initiation to close-out, ensuring adherence to study protocols and regulatory requirements.
- Created and analyzed excel spreadsheets and charts to review site activity, ensuring audit readiness and facilitating compliance resolution with sites.
- Performed routine site visits, including pre-study, initiation, monitoring, and close-out visits to ensure quality data collection and patient safety.
- Managed relationships with site investigators, study coordinators, and other clinical staff to ensure successful trial outcomes.
- Conducted site assessments and ensured regulatory documentation is complete and accurate.
- Facilitated study team meetings, directed study execution, and resolved emerging issues.
- Collaborated with cross-functional teams to address site-related queries and ensure project timelines are met.
- Mentored junior CRAs and assisted in their professional development through hands-on training and guidance.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support.
- Directed team tasks and developed project schedules, resource requirements, and timelines to maintain alignment with goals and objectives.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Executed studies to assess usability of solutions, analyze data, and deliver actionable recommendations to project team.
Clinical Research Associate II (CRA II)
Worldwide Clinical Trials
02.2009 - 02.2022
- Ensured timely submission of data from clinical trial sites and worked with site teams to resolve discrepancies.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Organized clinical trial documentation to meet rigorous site approval standards, ensuring compliance and readiness for audits.
- Facilitated communication between sites and sponsor, addressing protocol queries and ensuring documentation compliance to support trial integrity.
- Reported serious adverse events and ensured timely reporting to ethics committees and regulatory authorities to maintain participant safety and regulatory adherence.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
Education
Bachelor of Science - Human Services
Front Range Community College
Westminster, Colorado, CO05-2027
Skills
- Trial management
- Site management
- Regulatory compliance
- Regulatory documentation
- Ethics submissions
- Study protocols
- Monitoring visits
- Adverse event tracking
- Trial oversight
- Report writing
- Site operations coordination
- Action planning
- Conflict resolution
Certification
ICH/GCP
Timeline
Senior Clinical Research Associate (Sr. CRA)
Kelly Services
02.2022 - 02.2026
Clinical Research Associate II (CRA II)
Worldwide Clinical Trials
02.2009 - 02.2022
Bachelor of Science - Human Services
Front Range Community College