Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
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.
Essential Duties and Responsibilities:
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.
Prepares detailed reports surrounding study setup, study progress, and findings from monitoring/closeout visits.
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.).
With assistance, writes study reports and helps develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.).
Researches and collects information on regulatory/clinical requirements and standards.
Works on multiple projects.
Effectively supports project team to perform routine department tasks.
Elevates concerns or problems to management team and contributes to the day-to-day harmony within the department.
Adapts to changing priorities.
Acts as a study coordinator for in-house studies.
Conducts interim monitoring visits
This position will assume other duties as assigned
Nursing or diabetes experience desirable, but not mandatory.
GCP training is desirable. Past experience as a Clinical Research Aide or CRA is highly desirable.
Experience in the medical device industry