Sr Clinical Research Associate (Study Startup)

Company: Dexcom
Location: San Diego
Posted on: May 26, 2023

Job Description:

Meet the team:
About Dexcom:
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.
Position Summary:
Able to work under minimal supervision to plan and execute the design and start up activities of Dexcom-sponsored studies (including Sponsor-Investigator studies). Act as department representative/clinical startup leader on project teams. Works collaboratively with company's Biometrics, R&D and Regulatory Affairs groups to compile study start up documentation and/or tracking various study documentations. As needed, this role may support site qualification, activation, management, and monitoring.
Where you come in:
Primary Responsibilities (Study Startup Tasks):

• Partner with Program Management, Clinical Science, and Clinical Affairs management to develop and plan clinical studies.
• Write/review protocols, and study reports in consultation with stakeholders (R&D, Biostats, Marketing, etc.), Program Management, Clinical Science, and/or Clinical Affairs Manager.
• Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under direct supervision of Clinical Affairs Manager.
• In collaboration with Data Management, perform user acceptance testing (UAT) of electronic data capturing (EDC) systems.
• Assist with developing monitoring plan and conventions for Sponsor-Investigator and Dexcom-Sponsored studies.
• Maintain organization, preparation and ordering of supplies and equipment required for clinical studies.
• Draft clinicaltrials.gov submissions.
• Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
• Act as a study start up lead for multiple studies/projects simultaneously.
• Clearly demonstrate understanding of clinical study management/prioritization.
• Work independently to manage all clinical tasks and deliverables to meet clinical timeline.
• Communicate progress updates to Clinical Affairs management, Program Management, and the various functional groups (R&D, Biostats, Clinical Operations).
• Maintain thorough understanding of clinical regulations and standards (including changing regulations).
• Create and implement regular process improvements.
• This position assumes and performs other duties as assigned.
• Complete tasks under minimal or no direct supervision. As Needed Responsibilities:
  • Site qualification, activation, management, and monitoring. What makes you successful:
    • Study startup experience at various sponsor companies.
    • Nursing or diabetes experience desirable, but not mandatory.
    • Experience in the medical device industry and/or continuous glucose monitoring (CGM) is a plus.
    • Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS). 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
        • 15-25% Experience and Education
          • Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
            Exempt Salary Details
            The annual base salary range for this role is $91,400.00 to $152,300.00. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.
            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.
            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.

Keywords: Dexcom, San Diego , Sr Clinical Research Associate (Study Startup), Healthcare , San Diego, California