- Responsible for all aspects of study execution including start-up, maintenance, and close-out.
- Works cross-functionally with other Guardant Health departments (such as Bioinformatics, Clinical Operations, Regulatory Affairs, Client Services, etc.) to ensure timely execution of study protocols in accordance with Good Clinical Practices (GCPs).
- Primary operational point of contact for pharmaceutical partner(s)
- Identify barriers to timely and successful study execution and propose creative solutions in order to deliver project milestones.
- Assess feasibility of study timelines and pharmaceutical partner requirements.
- Coordinate with pharmaceutical partner to establish reporting requirements and align with internal stakeholders to deliver reports.
- Finalize Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) as needed.
- Oversee study monitoring to ensure compliance to the study monitoring plan by planning monitoring visit schedule, reviewing and approving monitoring reports, and providing guidance to monitors.
- Responsible for training of investigative site staff and providing ongoing educational assistance to ensure compliance with study protocol and applicable regulatory requirements.
- Develop study materials including Protocols, SIV slides, Lab Manuals, Communication Plans, etc.
- Oversee research use only sample processing operations.
- Mentor and lead for CRAs
- Bachelor’s degree (or higher) in science or health-related discipline
- 5+ years of clinical trial experience in Pharmaceutical, Biotech or CRO company. 2+ years direct trial management experience, preferably including clinical team management.
- Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
- Clinical experience, oncology, cancer center, inpatient or outpatient or physician office setting experience a plus
- Practical experience with clinical studies involving in vitro devices (IVD) a plus
- Practical experience with Companion Diagnostic (CDx) studies is highly preferred
- Experience with real-world data and pragmatic trials is a plus
- 3+ years of clinical trial experience as a CRA/Senior CRA in Pharmaceutical, Biotech or CRO company is highly preferred
- Solid organizational and business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
- Excellent problem solving ability necessary
- Excellent written and verbal communication skills in English
- Maintain therapeutic knowledge
- Flexible and solution seeking attitude
- Ability and willingness to travel 25%-50% of the time.
- Must have excellent knowledge of MS Office as well as project management and clinical trials software
- Driven to make a positive impact in cancer diagnosis and treatment
- Detailed oriented with an appetite to drive tasks to completion
- Ability to work well in a rapid-pace startup environment
- Ability to work well in a group
- Ability to work independently, with minimal supervision
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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 $114,900 to $154,900. 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 [email protected]
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.
To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.
Please visit our career page at: http://www.guardanthealth.com/jobs/
