Senior Clinical Research Associate

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

Position Summary:

The Senior Clinical Research Associate (CRA) is responsible for management and monitoring activities that will lead to successful execution of IVD clinical studies. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable.  The Sr. CRA engages with study investigators, vendors and internal/external stakeholders as a member of the Clinical Trial Operations team.

Essential Duties and Responsibilities:

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
• Independently generate project plans, especially those related to site management, monitoring and reporting.
• Mentor and provide guidance to junior monitors on best monitoring practices.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure that study management, data collection and subsequent data transfers are in accordance with outlined specifications (DTA/DTS). 
• Independently prepare accurate and timely trip reports.
• Ensure compliance to monitoring plans by scheduling monitoring visits and reviewing and approving monitoring reports.
• Organize and make presentations at Investigator Meetings
• Interact with internal groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Provide project management support to pharmaceutical partners.
• Thorough understanding of the principles of the assay and/or instrument and "hands-on" knowledge.

Qualifications

• Bachelor’s degree in life sciences or a related field with a minimum of 5 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring, and closeout visits) at a Pharmaceutical, Biotech, or CRO company OR
• Master’s degree in life sciences or a related field with a minimum of 3 years of clinical research monitoring experience.
• Experience in diagnostics and/or medical devices is preferred.
• Experience with companion diagnostics (CDx) is advantageous
• Oncology experience preferred
• Thorough knowledge of ICH/GCP Guidelines, including a basic understanding of regulatory requirements in other countries
• Advanced site monitoring skills
• The ability to thrive with minimal supervision
• The drive to resolve project-related problems and can prioritize workload for self and team
• Efficient and effective work habits in a matrix environment, internally and externally
• A flexible attitude to adjust to changing needs
• The ability and willingness to travel up to 10% of the time
• Excellent knowledge of MS Office as well as project management and clinical trials software

Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $105,600 to $142,560. The range does not include benefits, and if applicable, bonus, commission, or equity.