Clinical Research Associate II

Position Summary:

The Clinical Research Associate (CRA) is responsible for management and monitoring activities that will lead to successful execution of clinical studies. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable.  The 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.
• Involvement in the generation of project plans especially those related to site management monitoring and reporting
• Responsible for all aspects of study monitoring process (site initiation visits interim monitoring visits and close-outs visits) to ensure sites compliance to the study protocol and applicable regulatory requirements.
• Independently prepare accurate and timely visit reports.
• Ensure compliance with GCP/ICH guidelines and regulations including review of all required essential documents necessary for study initiation to ensure audit ready study files through duration of study
• Independently contribute to the development of study documents including but not limited to training slides protocol and reports.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Support trial team in ensuring that study management data collection and subsequent data transfers are in accordance with outlined specification (DTA/DTS).
• Actively participates as a member of the study team and contributes to cross functional project team.
• Maintain accurate professional and timely sponsor/site correspondence and communication
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Interact with internal groups to evaluate needs resources and timelines.
• Acquires an understanding of the principles of the assay and/or instrument and hands-on knowledge

Qualifications :

• Bachelors degree in life sciences or a related field with a minimum of 2 years of clinical research monitoring experience (including pre-study initiation routine monitoring and closeout visits) at a Pharmaceutical Biotech or CRO company OR
• Masters degree in life sciences or a related field
• Diagnostic and/or Medical device experience preferred
• 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 15% of the time
• Excellent knowledge of MS Office as well as project management and clinical trials software

Work Environment:

Employee may be required to lift routine office supplies and use office equipment.  Majority of the work is performed in a desk/office environment; however there may be exposure to high noise levels fumes and biohazard material in the laboratory environment.  Ability to sit for extended periods of time.

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 $90400 to $124300. The range does not include benefits and if applicable bonus commission or equity.

Within the range individual pay is determined by work location and additional factors including but not limited to job-related skills experience and relevant education or training. If you are selected to move forward the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however there may be exposure to high noise levels fumes and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities long-term conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to 

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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