Senior Clinical Research Associate - Pleasanton, CA

Summary:

The Senior Clinical Research Associate (Senior CRA) provides operational leadership, oversight, and mentorship to CRAs and Clinical Coordinators, acting as a liaison between Clinical Operations management and the site monitoring team. This role ensures high-quality monitoring, effective site management, regulatory compliance, and audit readiness at all times, while driving efficient study start-up timelines and compliant enrollment, and tracking of key project health metrics. The Senior CRA also plays a critical role in developing study-specific tools, resources, and training materials to support the CRA role and promote consistent execution across the team. The position offers various career development pathways including, but not limited to Clinical Operations management, CRA Management, and Project Management.

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.
• 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.
• Support onboarding of new team members and facilitate knowledge sharing across the monitoring team.
• 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.

Who You Will Report To:

• Sr. Director, Clinical Operations

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.

Preferred Qualifications:

• Live within one hour of a major airport

What We Offer:

At Calyxo, you will be part of a knowledgeable, high achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $105,000 - $125,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company.
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation