Full Job Description
Company Description
We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.
Job Description
The Senior Clinical Research Associate 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 II 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
Involved in the development of protocols and Case Report Forms (CRFs) as assigned
Manage the identification, selection and feasibility processes
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 the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitor for missing or implausible data
Prepare accurate and timely trip 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
Qualifications
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology
A minimum of 4 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) at a Pharmaceutical, Biotech or CRO company. 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
Excellent knowledge of MS Office as well as project management and clinical trials software
Additional Information
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 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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