Senior Clinical Research Associate, IVD

Senior Clinical Research Associate, IVD

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Job Description

The Senior Clinical Research Associateis 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.

• 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 4years 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 experiencepreferred
• 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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