Senior Clinical Research Associate - Pleasanton, CA

Calyxo, Inc. is a medical device company seeking a Senior Clinical Research Associate to provide operational leadership and oversight to CRAs and Clinical Coordinators. The role involves ensuring high-quality monitoring, effective site management, regulatory compliance, and audit readiness, while driving efficient study start-up timelines and compliant enrollment.

Requirements

• Minimum 5 years clinical research experience in industry sponsored medical device trials.
• 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.

Benefits

• 401(k)
• healthcare insurance
• paid vacation
• Stock options – ownership and a stake in growing a mission-driven company.