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Senior Clinical Research Associate
153521
Posted:
29/10/2024
Requirements:
- 120000 USD - 145000 USD
- Palo Alto, United States
- Permanent
As a 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