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:
Are you someone who wants tomake a meaningful impact in the field of clinical trials?Join our team as a Clinical Research Analyst at Dexcom.In this crucial role, you will manage and conduct clinical studies in strict accordance with study protocols, Good Clinical Practice (GCP), ICH Guidelines, and Dexcom's Standard Operating Procedures (SOPs). You will oversee the execution of clinical trials from start-up through subject recruitment, scheduling, and consenting, while also providing training to participants. Your responsibilities will include collecting regulatory documents, conducting study visits, performing SMBG testing, and ensuring data is entered accurately and promptly. You will also manage and report on adverse events, serious adverse events, and deviations, while preparing detailed IRB close-out reports. If you are committed to excellence in clinical research and eager to make a significant impact, we would love to welcome you to our team!
Where you come in:
You'reresponsible for identifying and escalating safety events and major protocol deviations
You will prepare supplies and account for devicesrequiredfor clinical studies
You will write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
You will incorporate understanding of studyobjectivesand 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 collaborate with project management toestablishand maintain study timelines
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 willassistmanagement 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 Regulatory Authorities, IRB, and key opinion leaders.
You will complete tasks under minimal supervision.
What makes you successful:
Youpossessthe ability and judgment to work under minimal supervision, effectively planning and executing study operations. This includes on-site and remote monitoring,requestingand tracking supplies, managing documentation, training sites and team members, and generating progress reports.
You have the skill and experience to work cross-functionally, collaborating with various teams to achieve common goals.
You bring a strong background in Good Clinical Practice (GCP) and clinical studies, with experience as a Clinical Research Associate (CRA). Familiarity with the medical device industry and/or diabetes research is a plus.
Youcan managemultiple studies concurrently andcollaboratingeffectively with co-monitors to reduce the overall time from Last Patient Out to database lock while enhancing site compliance.
You have experience using electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).
Whatyou'llget:
A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.
Afull andcomprehensive benefitsprogram.
Growth opportunities on a global scale.
Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
Anexcitingandinnovative,industry-leading organizationcommitted 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 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
#LI-hybrid
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 unsolicitedresumes/applications.