Meredith Coffroth

About Meredith Coffroth

Lead Clinical Research Coordinator at SCRC. Experience working on a wide variety of phase II and clinical trials, specializing in women’s health, migraines and vaccines. Oversee and manage Clinical Operations team. University of Washington graduate passionate about healthcare, research and public and global health.

Experience

1. Lead Clinical Research Coordinator

   Seattle Clinical Research Center

   Sep 2022 — Present

   Coordinate Phase I-IV clinical trials including, but not limited to, the following indications: Vaccines, Vasomotor Symptoms, Contraception, Sexual Dysfunction, Contraception, Overactive Bladder, and Migraines.• Became Lead CRC in 2022• Initiation, operation, and completion of protocols in accordance with FDA code of federal regulations, Good Clinical Practice (GCP), and ICH guidelines. • Documentation of protocol deviations/violations, and implementing plans of action to prevent future violations.• Evaluate subject eligibility, oversee informed consent/reconsent process, and ensure completion of study visit procedures.• Dispense investigational product with detailed instructions on dosing requirements.• Monitor subject’s investigational product compliance and other study procedures (i.e. diary completion).• Collaborate with monitors during routine site audits to ensure site\'s data collection process is concise and discrepancies are resolved in a timely manner. • Serve as liaison between site and sponsoring pharmaceutical companies, contract research organizations, and Independent Review Boards. • Prepare study specific documents regarding serious adverse events and noncompliance for IRB submission• Assist in potential study leads, including managing pre-study site visits with sponsors. • Attend investigator meetings for protocol training.• Train and supervise site staff members (recruitment, lab, coordinators) on trial-specific responsibilities for each protocol.• Oversee management of Clinical Operations team of coordinators, research assistants, and interns. • Train new staff on conduct of clinical trials, Good Clinical Practice (GCP), job specific responsibilities, and more.

Education

• University of Washington

  Bachelor of Arts - BA, Medical Anthropology and Global Health

  2016 — 2020