Clinical Coordinator 2 at Dexcom, Inc in San Diego, California

Job Description:

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.



Meet the team:



This Clinical Coordinator will plan and execute clinical studies, including but not limited to, protocol & document creation, 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.



Where you come in:

• 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
    
    
  
  
  
  


• Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.
  
  


• Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision.
  
  


• Coordinate preparation of key documents for trial site submission to IRBs.
  
  


• 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.
  
  

What makes you successful:

• 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
  
  

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:

• 0 - 5%
  
  

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience.
  
  

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.


Salary:
$75,200.00 - $125,300.00 Apply Now