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Clinical Research Associate I
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Clinical Research Associate I (In-House)
- Contract role for 6 months to start with potential to extend. Will be 40 hours per week, but may be more part time in the beginning until things ramp up on the project.
- Hybrid role: Mostly remote with requirement to come onsite 1- 2x/week to office (TBD, most likely a WeWork space in San Ramon, CA).
- Main Skills: Understand all regulatory documents related to startup of clinical trials, experience with IRB submissions, medical device experience, ETMF/EIFF experience and helping to manage device accountability
We are seeking a high quality, ambitious and experienced in-house clinical research associate (CRA I) to support our boutique CRO. As an important member of the team, we will spend time teaching you about our organization and its aims and ambitions so that you can quickly become a productive and valued part of our team. You will support our Clinical Operations team for the successful delivery of our active projects. The Clinical Research Associate (CRA) supports global and regional clinical project/trial managers in the planning, designing, executing, monitoring, and reporting of clinical trials. The In-House Clinical Research Associate partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; investigative site recruitment & feasibility; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.
