Demo

SENIOR CLINICAL RESEARCH ASSOCIATE

Meet
Sonoma, CA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/15/2025

Meet has partnered with one of our top biotech clients in the bay area. They are seeking a seasoned Senior Clinical Research Associate to join their growing team. As a Senior Clinical Research Associate, you will play a crucial role in the planning, execution, and monitoring of medium and large-sized clinical trials. You will ensure that studies are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP), and company policies. This is a significant opportunity to progress therapeutics for metabolic and oncologic conditions.

Responsibilities :

  • Study Management : Assist in the design and implementation of clinical study protocols, case report forms, and informed consent documents. Work closely with Study Lead across projects
  • Site Monitoring : Conduct regular site visits to ensure compliance with study protocols, GCP, and regulatory requirements. Monitor patient recruitment and retention.
  • Data Collection & Management : Review and verify data quality and accuracy. Assist in data entry and maintenance of clinical databases. Ensure Trial Master File is maintained.
  • Regulatory Compliance : Ensure that all clinical trials are conducted in compliance with local, national, and international regulations. Prepare documentation for regulatory submissions and audits.
  • Collaboration : Work closely with investigators, site staff, and cross-functional teams to facilitate smooth study operations and resolve any issues that arise. Partner with CMC team for drug supply forecasting
  • Training : Provide training and support to site staff on study protocols, procedures, and data collection methods.
  • Reporting : Prepare regular progress reports and communicate findings to project teams and management.

Requirements :

  • BS / BA in relevant discipline and at least 4 years of industry experience working across clinical research functions - ideally managing most aspects of clinical studies
  • Experienced as a CRA ideally for a Sponsor company and ideally in a CRO or a CRA / field monitor environment
  • Understanding of clinical trials process, SOPs, medical terminology, and US and GCP / ICH regulations
  • Excellent written and verbal communication
  • Contact :

    Please reach out to Payton Baker at 312-878-1824 or payton.baker@meetlifesciences.com to learn more. Correspondence will be confidential.

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