Clinical Research Associate

Jessica Langheimer

*** ******* ******, *** *********, CA 94107 • 650-***-**** • ***************@****.***

Profile

A Clinical Research Associate with entry-level experience, specializing in quality control, audits, continuous improvement, and GCP regulations. Adept at analyzing complex data sets and identifying opportunities to enhance the quality of clinical research initiatives.

Professional Experience

Clinical Research Associate, Arkline Pharmaceuticals, San Francisco, CA

September 2021 – Present

Wrote clinical trial documentation for a pharmaceutical company analyzing the efficacy of a new antidepressant, including consent forms, study protocols, and QC guidelines

Ensure compliance with FDA, ICH, and GCP regulations, conduct study audits, develop SOPs, and identify opportunities to reduce protocol deviations

Coordinate with research coordinators to ensure the accuracy and transparency of data

Clinical Research Internship, Solaris Biomedical, San Francisco, CA

May 2021 – September 2021

Provided support for the planning and execution of clinical studies under the direction of the CRA, including reviewing documentation and driving process improvements

Ensured compliance with ethical and scientific standards for data collection and analysis

Education

Bachelor of Science (B.S.) Clinical Research

University of San Francisco, San Francisco, CA September 2017 – May 2021

Key Skills

• Clinical Research • GCP Regulations • Clinical Trial Documentation

• Process Improvement • Quality Control

Certifications

Certified Clinical Research Associate (CCRA), ACRA, 2021

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