February 15
π½ Illinois β Remote
π€ Texas β Remote
π΅ $90k - $140k / year
β° Full Time
π’ Junior
π‘ Mid-level
π¬ Research Analyst
β’ Spirair, a venture capital-backed medical device company, was co-founded by two Stanford Biodesign and Innovation fellows. β’ We are looking for a Clinical Research Associate based in the Southern, Mid-Southern, or Western US. β’ This role involves performing Spirair sponsored clinical studies and supporting the clinical department. β’ Must have demonstrated knowledge of GCP, ICH guidelines, and FDA regulations. β’ The ideal candidate would have medical device experience.
β’ Perform independent monitoring of sites, including: conducting site qualification, initiation, interim monitoring visits, and close-out visits. β’ Maintain frequent contact with investigators and coordinators. β’ Assist with clinical case support including device training and case proctoring. β’ Assist with management of site enrollment goals. β’ Manage trial master files for assigned projects. β’ Assist with document review of clinical protocols and other materials. β’ Set up and track documentation including clinical recruitment and project status. β’ Ensure all study supplies are ordered for assigned projects. β’ Coordination of internal and external conference calls. β’ Review and resolve queries in clinical data with clinical sites. β’ Assist in review of clinical study reports and budget negotiation. β’ Conduct clinical site invoice management and reconciliation. β’ Ensure regulatory compliance of investigational sites. β’ Support ongoing projects as needed. β’ Support the company Quality Policy and Quality System. β’ Attend relevant clinical research professional meetings. β’ Participate in recruitment / hiring of Clinical staff.
β’ Spirair offers highly competitive salaries, equity, and benefits, including medical, dental, and vision insurance. β’ Paid time off, and 401(k). β’ Legal authorization to work in the US is required. β’ We are an equal opportunity employer and value diversity at our company.
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