Clinical Coordinator 1
Dexcom, Inc

Job Info

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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.

Summary

This Clinical Coordinator will execute clinical studies, including but not limited to, recruitment, consenting, screening, and conducting study visits. A successful coordinator will be knowledgeable in each of the provided areas but also demonstrate a flexible and enthusiastic mindset in establishing new and creative approaches. This role will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts.

Essential Duties and Responsibilities

• Partner with Clinical Affairs management to develop and execute clinical studies.
  • Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Dexcom's SOPs
  • Execute assigned clinical trials including start up, subject recruitment & scheduling, consenting, screening, subject training, collection of regulatory documents, conducting study visits, performing SMBG testing, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports
  • Responsible for identifying and escalating safety events and major protocol deviations
  • May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager. May also propose and implement corrective and preventative actions
  • Prepare supplies and account for devices required for clinical studies
  • Set-up IT equipment for studies
  • Complete testing of electronic data capturing systems
  • Write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners
  • Incorporate understanding of study objectives and key data points when planning for each assigned protocol
  • Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.)
  • Communicate effectively and professionally with coworkers, leadership, and study subjects
• Collaborate with project management to establish and maintain study timelines
  • Clearly demonstrate understanding of clinical study management/prioritization
  • Manage all clinical tasks and deliverables to meet clinical timeline
• Assists management with departmental audits of clinical studies and procedures
• Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders
• This position assumes and performs other duties as assigned

Preferred Qualifications

• Certification as a clinical research associate or coordinator (e.g., CCRA, CCRC)
• Previous experience as a MA or LVN a plus
• Monitoring clinical studies experience or experience as a study coordinator is a plus
• Clinical Trial Management System (CTMS) experience.
• Experience in exercising good judgment in measuring risk vs. business needs
• Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
• Excellent organizational skills, attention to detail and a Data-driven, decision-making mindset
• Experience in continuous glucose monitoring (CGM) is a plus

Experience and Education

• Bachelor's degree in a technical discipline, and a minimum of 0-2 years related experience
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project
• Knowledge of GCP (Good Clinical Practice)
• Excellent communication (written and verbal) and presentation skills
• Strong organizational skills and ability to deal with competing priorities
• Strong critical thinking ability with the ability to work independently
• Willing to work, hands-on, in an extremely fast paced environment with high attention to details and accuracy
• Strong interpersonal communication skills and ability to work effectively on cross-functional & global teams

Compensation Data

The annual base salary range for this role is $56,200 to $93,600. 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.

This job has expired.