Clinical Coordinator II
Dexcom, Inc

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the team:

This Clinical Coordinator will plan and implement clinical studies, including but not limited to, crafting protocols and documents, recruiting, acquiring consent, screening, and conducting study visits. A successful coordinator will possess knowledge in each of the provided areas but should also exhibit a flexible and hard-working mentality in devising new and creative approaches. This role will demand inventive and critical thinking, attention to detail, and a strong ability to prioritize efforts.

Where you come in:

• You will collaborate with Clinical Affairs management to develop and complete clinical studies.
• You will conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Dexcom's SOPs.
• You will complete assigned clinical trials, including start-up, subject recruitment, scheduling, and consenting. You will also perform screening, subject training, and collection of regulatory documents. Additionally, you will conduct study visits, perform SMBG testing, ensure timely data entry and resolution of queries, manage and report adverse events, serious adverse events, and deviations, and provide IRB close-out reports.
• You will be responsible for identifying and advancing safety events and major protocol deviations.
• You will 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.
• You will prepare supplies and account for devices required for clinical studies.
• You will set-up IT equipment for studies.
• You will complete testing of electronic data capturing systems.
• You will write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
• You will incorporate understanding of study objectives and key data points when planning for each assigned protocol.
• You will develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.).
• You will communicate effectively and professionally with coworkers, leadership, and study subjects.
• You will collaborate with project management to establish and maintain study timelines.
• You will clearly demonstrate understanding of clinical study management/prioritization.
• You will manage all clinical tasks and deliverables to meet clinical timeline.
• You will assist with the management of studies by coordinating daily operations including methods, workflow, and implementation of procedures.
• You will assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision.
• You will coordinate preparation of key documents for trial site submission to IRBs.
• You will assist management with departmental audits of clinical studies and procedures.
• You will 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.
• You will complete tasks under minimal supervision.

Education and Experience Requirements:

• Typically requires a Bachelor's degree in a technical field, with 2-5 years of related experience or a Master's degree with 0-2 years' equivalent 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 in a dynamic environment that requires strong attention to detail and accuracy.
• Strong interpersonal communication skills and ability to work effectively on cross-functional and global teams.
• Active RN, BSN, or LVN license in Arizona.
• Certification as a clinical research associate or coordinator (CCRA or 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, upbeat, 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 attitude.
• 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:

• 25 to 50%
• Local to Mesa, Arizona and willing to travel to San Diego, California.

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

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