Senior Clinical Research Associate

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 projectsSite 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 forecastingTraining: 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 studiesExperienced as a CRA ideally for a Sponsor company and ideally in a CRO or a CRA/field monitor environmentUnderstanding of clinical trials process, SOPs, medical terminology, and US and GCP/ICH regulationsExcellent written and verbal communicationContact:Please reach out to Payton Baker at 312-878-1824 or payton.baker@ to learn more. Correspondence will be confidential.

Created: 2025-01-07