Company Description|Job Description
ABOUT OUR COMPANY
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 & 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 & new products. We're working on some exciting ones, including in early detection, where the impact on patients can be profound. The LUNAR program aims to establish new paradigms in early-stage cancer detection & disease monitoring.
The Clinical Research Associate ll (CRA)is responsible for management & monitoring activities that will lead to successful execution of clinical studies. They will proactively identify & resolve clinical project issues & participate in process improvement initiatives as applicable. The CRA engages with study investigators, vendors & internal/external stakeholders as a member of the Clinical Trial Operations team.
- Responsible for all aspects of study site monitoring including routine monitoring & close-out of clinical sites, maintenance of study files, conduct of pre-study & initiation visits.
- Involvement in the generation of project plans, especially those related to site management, monitoring & reporting.
- Involved in the development of protocols & Case Report Forms (CRFs) as assigned.
- Manage the identification, selection & feasibility processes.
- Ensure the study staff who will conduct the protocol have received the proper materials & instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures & 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 & monitor for missing or implausible data.
- Prepare accurate & timely trip reports.
- Organize & make presentations at Investigator Meetings.
- Interact with internal groups to evaluate needs, resources & timelines.
- Act as contact for clinical trial supplies & other suppliers (vendors) as assigned
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology
- Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring & 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 & can prioritize workload for self & team
- Efficient & effective work habits in a matrix environment, internally & externally.
- A flexible attitude to adjust to changing needs
- The ability & willingness to travel up to 70% of the time.
- Excellent knowledge of MS Office as well as project management & clinical trials software.
All your information will be kept confidential according to EEO guidelines.
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 & will not be discriminated against on the basis of disability.