Clinical Research Associate 1

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

Summary

Implement and monitor clinical studies at participating study sites according to Good Clinical Practices (GCP), ICH Guidelines, and the Code of Federal Regulations (CFR). Works with other CRAs, Managers, and/or Executive Director of Clinical Affairs to assist in the conduct of Dexcom-sponsored clinical studies (including In-House studies), and/or Dexcom-supported external studies (Investigator-initiated, industry-sponsored, etc.). 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.

Where you come in:

• 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, designs, 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 the project team to perform routine department tasks.

• Elevates concerns or problems to the management team and contributes to the day-to-day harmony within the department.

• Adapts to changing priorities.

What makes you successful:

• You must be able to perform each essential duty satisfactorily.

• You must be able to work independently and collaborate with the Clinical Research team.
  

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .

• A full and comprehensive benefits program.

• Growth opportunities on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

• 25 to 50%

• Traveling up to 30% of the time can be expected. The employee may be requested to travel on extended-length trips, overseas travel, and nights/weekends as needed.

Experience and Education

• Bachelor’s degree in a technical skill, ideally in a science or health-related field; nursing or diabetes experience desirable, but not mandatory.

• Minimum of 0-2 years related experience, such as direct Clinical Research Associate experience (or an equivalent combination of education, professional training, and knowledge).

• GCP training is highly desirable. Experience as a CRA or Clinical Research aide is highly desirable.

Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

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 Dexcom Talent Acquisition at talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link .

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

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