Senior Clinical Research Associate

Senior Clinical Research Associate

Location: San Jose/San Francisco, CA Type: Embedded Salaried Contract Compensation: $140,000.00 - $145,000.00 Work Model: Remote with Regional Travel Hours: 40.0 hours/week

We are looking for a Senior Clinical Research Associate (CRA) to support end-to-end site management from initiation through closeout, ensure data quality, subject protection, and compliance with ICH-GCP and regulatory requirements. This is a remote/home-based role requiring regional travel (up to ~70%) for onsite monitoring. The candidate should be based out of the San Francisco Bay Area.

Responsibilities

• Provide site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout.
• Ensure high-quality data collection, timely adverse event reporting, subject protection, and compliance with the protocol.
• Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment to meet targets.
• Collaborate with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues impacting trial milestones.
• Train and support external trial staff regarding CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability, temperature monitoring, query resolution, essential document collection, and ITF filing.
• Identify objectives for scheduled monitoring visits; ensure visit objectives are achieved to meet protocol and SOP timelines.
• Prepare and complete monitoring visit reports and follow-up letters within established timelines.
• Complete system training (IMPACT, IV/WRS, EDC, CATS, CONCUR, etc.) to adhere to protocol and SOP timelines.
• Proactively use EDC and other data systems for site visits and source data verification in coordination with data management teams.
• Identify potential risks and take proactive measures to prevent or mitigate them.
• Participate in sponsor and regulatory audits, preparing site records, addressing auditor questions, supporting during the audit, and preparing responses in compliance with guidelines.
• Act as back-up monitor during absences as requested.
• Perform other tasks as assigned by management.

Requirements

• Holds a BA/BS degree in relevant field.
• Minimum of 4+ years of CRA monitoring experience (preferably 5+ years in the field).
• Industry experience: 6+ years in clinical research.
• Experience with remote monitoring and risk-based monitoring is preferred.
• Strong understanding of ICH-GCP, regulatory, ethics, and company SOPs.
• Experience managing site recruitment and retention strategies.
• Ability to collaborate effectively with trial teams and communicate site progress.
• Proficiency in EDC systems and other clinical data management tools (e.g., IMPACT, IV/WRS, EDC, CATS, CONCUR).
• Up to 70% travel, including driving, flying, or trains to various sites.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.