Summary
Overview
Work History
Education
Skills
Certification
Work Availability
Timeline
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Teresa Rodriguez

Teresa Rodriguez

Fort Collins,CO

Summary

Highly experienced Senior Clinical Research Associate with 26 years of expertise in overseeing and monitoring Phase I-IV clinical trials. Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial methodologies. Proven track record in collaborating with cross-functional teams, ensuring compliance with study protocols, and safeguarding patient safety. Adept at training junior staff, managing sponsor relationships, and handling multiple clinical sites.

Senior Research Associate specializes in establishing project objectives, developing experimental plan and effectively prioritizing tasks to meet time sensitive delivery goals. Serves as point person for executing clinical

research projects and disseminating findings to leadership. Displays strong written and oral communication skills to present complex analyses effectively.

Overview

29
29
years of professional experience
1
1
Certification

Work History

Senior Clinical Research Associate (Sr. CRA)

ICON PLC
02.2022 - 07.2025
  • Oversaw and monitored multiple clinical trials from initiation to close-out, ensuring adherence to study protocols and regulatory requirements.
  • Performed and created excel spreadsheets and charts to gather information needed to review site activity and ensure the site was audit ready at all times and created charts of sites that were not compliant for easy access to review and work with sites regarding the issues and assisted them with correcting the urgent issues.
  • 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 ensure regulatory documentation is complete and accurate.
  • Completed a detailed written report of the site visit.
  • Lead study team meetings, providing guidance on study execution and troubleshooting issues as they arise.
  • Collaborated with cross-functional teams to address site-related queries and ensure project timelines are met.
  • Mentored junior CRAs and assist in their professional development through hands-on training and guidance.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support.
  • Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.

Clinical Research Associate II (CRA II)

Worldwide Clinical Trials
02.2009 - 02.2022
  • Conducted site monitoring visits, ensuring compliance with protocol, GCP guidelines, and sponsor requirements.
  • Ensured timely submission of data from clinical trial sites and worked with site teams to resolve discrepancies.
  • Assisted in the preparation and maintenance of study files, including regulatory documentation, monitoring reports, and consent forms.
  • Facilitated communication between sites and the sponsor, handling protocol queries and ensuring documentation compliance.
  • Reported any serious adverse events and ensured prompt reporting to ethics committees and regulatory authorities.
  • Completed a detailed written report of the site visit.

Clinical Research Associate (CRA)

Covance
02.1996 - 02.2009
  • Monitored multiple clinical trials from initiation to close-out, ensuring adherence to study protocols and regulatory requirements.
  • 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 ensure regulatory documentation is complete and accurate.
  • Completed a detailed written report of the site visit.

Education

High School Diploma -

Ranum High
Denver, CO
05-1989

Skills

  • Proficient in clinical trial management with Medidata
  • Proficient in Oracle trial management tools
  • Experience with Rave data management
  • Data capture proficiency in Veeva Vault
  • Electronic Data Capture: Inform
  • Electronic Data Capture: Medidata
  • Microsoft Office Suite
  • Adverse event monitoring tools
  • Ethics review submissions

Certification

ICH/GCP

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Senior Clinical Research Associate (Sr. CRA)

ICON PLC
02.2022 - 07.2025

Clinical Research Associate II (CRA II)

Worldwide Clinical Trials
02.2009 - 02.2022

Clinical Research Associate (CRA)

Covance
02.1996 - 02.2009

High School Diploma -

Ranum High

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