Senior Clinical Research Associate - Pleasanton, CA

Key Responsibilities

• Participate in site feasibility and qualification, assessing site capabilities, resources, and experience.
• Provide recommendations to Clinical Operations management on site selection based on operational and strategic fit.
• Support and help drive efficient study start-up activities by coordinating closely with CRAs and Contracts teams.
• Conduct site qualification, initiation, monitoring, and closeout visits (on-site and remote).
• Perform source data verification against case report forms and resolve queries in a timely manner.
• Review adverse events, serious adverse events, concomitant medications, and medical histories for accuracy and compliance.
• Oversee CRA and Clinical Coordinator activities to ensure effective site management, protocol compliance, and adherence to SOPs and regulatory requirements.
• Assist in the review and manage revisions to monitoring visit reports, follow-up letters, and related documentation.
• Escalate to Clinical Operations management when audit-readiness compliance gaps are identified.
• Oversee site management activities throughout the trial lifecycle, from feasibility through close-out.
• Facilitate Site Management Meetings to ensure monitoring and project team alignment.
• Lead the tracking and reporting of key operational metrics for providing regular project health updates to management.
• Oversee study tracker maintenance to ensure accurate, up-to-date information; follow up with CRAs to resolve gaps or discrepancies.
• Support development and execution of enrollment strategies to meet recruitment goals.
• Oversee timely eTMF filing of essential documents by CRAs and site staff, addressing gaps or quality issues as needed.
• Maintain eTMF audit readiness for all assigned studies; promptly escalate to Clinical Operations Management when standards are not met.
• Create and maintain study-specific tools, job aids, and training materials to support CRAs and Clinical Coordinators.
• Absorb and assist in developing training content for CRAs to ensure consistent monitoring practices, site management standards, and eTMF compliance.
• Mentor and train CRAs and Clinical Coordinators on study-specific requirements, monitoring plans, site management best practices, eTMF procedures, and quality standards.
• Serve as the primary escalation point for site-level or CRA-level issues, ensuring timely resolution.
• Proactively identify risks to study timelines, data quality, or compliance and escalate as needed.
• Implement corrective and preventive actions (CAPAs).
• Function as the communication bridge between Clinical Operations Management and site-facing staff.

  Requirements

  • Education: Must have a minimum of a bachelor’s degree in a health or science related field
  • Minimum 5 years clinical research experience in industry sponsored medical device trials.
  • Work location: Pleasanton (3-days/week optional)
  • Travel: up to 50%
  • Full time employment
  • Prior urology clinical trial experience.
  • Experience with all four types of visits – SQV, SIV, IMV, COV.
  • Proven ability to communicate with study physician and site staff, manage complex sites and troubleshoot issues with minimal supervision.
  • Strong self-management skills with the ability to work autonomously and prioritize tasks effectively in a remote setting.
  • Demonstrated ability to engage constructively in a team setting, fostering collaboration and contributing to achieving project milestones.
  • Effective communication and conflict-resolution skills.
  • Strong presentation skills.
  • Must be detail oriented.
  • Proficient knowledge of Microsoft Office.
  • Prior experience in urology or urology-focused clinical trials.
  • Knowledge of medical device approval pathways.
  • Advanced knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
  • Compliance with relevant county, state, and Federal rules regarding vaccinations.