Sr. Clinical Research Associate

7 days ago

Manila, National Capital Region, Philippines Dexcom Full time

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 to make 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:

  1. You're responsible for identifying and escalating safety events and major protocol deviations.

  2. You will prepare supplies and account for devices required for clinical studies.

  3. You will write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners.

  4. You will incorporate understanding of study objectives and key data points when planning for each assigned protocol.

  5. You will develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.).

  6. You will collaborate with project management to establish and maintain study timelines.

  7. You will manage all clinical tasks and deliverables to meet clinical timeline.

  8. You will assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.

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

  10. You will coordinate preparation of key documents for trial site submission to IRBs.

  11. You will assist management with departmental audits of clinical studies and procedures.

  12. You will collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with Regulatory Authorities, IRB, and key opinion leaders.

  13. You will complete tasks under minimal supervision.

What makes you successful:

  1. You possess the ability and judgment to work under minimal supervision, effectively planning and executing study operations. This includes on-site and remote monitoring, requesting and tracking supplies, managing documentation, training sites and team members, and generating progress reports.

  2. You have the skill and experience to work cross-functionally, collaborating with various teams to achieve common goals.

  3. 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.

  4. You can manage multiple studies concurrently and collaborating effectively with co-monitors to reduce the overall time from Last Patient Out to database lock while enhancing site compliance.

  5. You have experience using electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).

What you'll get:

  1. A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

  2. A full and comprehensive benefits program.

  3. Growth opportunities on a global scale.

  4. Access to career development through in-house learning programs and/or qualified tuition reimbursement.

  5. 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 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

#J-18808-Ljbffr

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