Dexcom
Sr Clinical Research Associate (Finance)
Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
Summary:
Able to work independently to implement and monitor clinical studies at participating study sites according to FDA's Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Works with Clinical Affairs management to plan and execute the design and conduct of Dexcom-sponsored (including In-House studies). Responsible for overall study planning and ensuring that all site visits, monitoring, data collection, reports, and ancillary requirements are appropriately assigned and executed to meet company deadlines, quality expectations, and priorities. Serves as department representative/clinical project leader on project teams. Works collaboratively with company's Biometrics, R&D and Regulatory Affairs groups to compile study results, reports and/or tracking various study documentation.
Functional Description: Technical Individual Contributor
Designs, plans and implements the overall direction of clinical research projects. Evaluates and analyzes clinical data. Must have knowledge in reference to good clinical practices regulations and standard operating procedures. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms. Conducts clinical monitoring of field sites to supervise and coordinate clinical studies. May write protocols. May require travel to field sites.
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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.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.
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