Clinical Study Coordinator (Onsite)

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

(This position requires to be onsite) 

The Clinical Study Coordinator is responsible for monitoring and management for clinical studies performed at Guardant Health, and assisting with their set up and close out. The work requires keeping meticulous and organized records, excellent attention to detail, the ability to prioritize, and to be flexible with tasks and schedules.

Essential Duties and Responsibilities:

• Facilitate the coordination and management of clinical studies
• Prepare records for trial monitoring activities and study binder maintenance
• Host monitoring visits and close out action items in a timely manner
• Identify high complexity problems which adversely affect clinical studies
• Assist with training of new study coordinators
• Assist with developing Standard Operating Procedures or supplemental study material
• Review protocols and procedures for clinical studies and compare with the laboratory’s standard operating procedures
• Document study related nonconformance reports and corrective actions taken when test systems deviate from the laboratory’s established performance specifications for clinical studies
• Assist with process improvement activities for the Clinical Study Coordination team
• Participate in internal and external audit activities, as needed
• Perform other miscellaneous duties as assigned and assist others as time allows

Qualifications

• Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science, or related field
• A minimum of 1 year experience in a CLIA, CAP-accredited laboratory preferred
• A minimum of 1 year of experience as a clinical research coordinator preferred, ideally in a lab or device setting
• Project management experience preferred
• Knowledge of ICH/GCP guidelines, including basic understanding of regulatory requirements in other countries, preferred
• Working knowledge of local, state, and federal laboratory regulations
• Able to integrate and apply feedback in a professional manner
• Able to prioritize and drive to results with a high emphasis on quality
• Proven ability to demonstrate high attention to detail and accuracy
• Able to work effectively in a team environment and build strong working relationships
• Effective interpersonal skills and ability to effectively communicate (verbal and written) across all levels of the company
• Other: Clinical Laboratory certification (MT, ASCP or equivalent) or certification as a clinical research professional (SOCRA, ACRP) is desirable

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. Hours and days may vary depending on operational needs.
• Some lifting (up to 25 pounds) may be necessary

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.

Covid Vaccination Policy:  Guardant Health requires all employees to be fully vaccinated. We follow the CDC guidelines for the definition of “fully vaccinated”, meaning an employee is consider fully vaccinated against COVID-19 after receiving the second dose of a two-dose vaccine or one dose of a single-dose vac