Website Guardant Health
Guardant Health
Company : Guardant Health
Job Description
Position Summary:
The Senior Clinical Research Associate (CRA) is responsible for management and monitoring activities that will lead to successful execution of IVD clinical studies. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The Sr. CRA 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.
Independently generate project plans, especially those related to site management, monitoring and reporting.
Mentor and provide guidance to junior monitors on best monitoring practices.
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 that study management, data collection and subsequent data transfers are in accordance with outlined specifications (DTA/DTS).
Independently prepare accurate and timely trip reports.
Ensure compliance to monitoring plans by scheduling monitoring visits and reviewing and approving monitoring 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
Provide project management support to pharmaceutical partners.
Thorough understanding of the principles of the assay and/or instrument and "hands-on" knowledge.