Job Description: Implement and monitor clinical studies at participating study sites according to the FDA Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Works with other CRAs and Clinical Affairs management to assist in the conduct of Dexcom-sponsored clinical studies (including In-House studies). Responsible for conducting site visits, monitoring, and performing all ancillary requirements in executing clinical studies to ensure proper data collection and write-up for documentation or submission of clinical study data. Job Responsibilities: Conducts supervisored interim monitoring visits Effectively supports project team to perform routine department tasks. Adapts to changing priorities. This position will assume other duties as assigned Prepares detailed reports surrounding study setup, study progress, and findings from monitoring/closeout visits. With assistance, writes study reports and helps develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.). Works on multiple projects. With supervision, plans, conducts and monitors Dexcom-sponsored clinical studies (including In-House studies) and provides requested clinical support to externally-sponsored studies (investigator-initiated, industry-sponsored, etc.). Elevates concerns or problems to management team and contributes to the day-to-day harmony within the department. Acts as a study coordinator for in-house studies. With supervision, assesses clinical investigators, study staff, and contract research organizations (if applicable) for compliance with study protocols, regulations, and Dexcom Standard Operating Procedures. Implements or escalates appropriate corrective action as needed. Researches and collects information on regulatory/clinical requirements and standards. Job Requirements: GCP training is desirable. Past experience as a Clinical Research Aide or CRA is highly desirable. Experience in the medical device industry Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 0-2 years related experience. Job Details: Company: Dexcom Vacancy Type: Full Time Job Location: San Jose, CA, US Application Deadline: N/A Apply Here careers-trivia.com
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