Job Description

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 [email protected] to learn more. Correspondence will be confidential.

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