Note: The job is a remote job and is open to candidates in USA. Dexcom is a global leader in continuous glucose monitoring technology focused on improving health outcomes. The Sr. Clinical Research Associate will support clinical study execution for product development and validation, manage site relationships and study operations, ensure data quality and compliance, and contribute to regulatory and process improvement activities.
Responsibilities
- As a Sr CRA, you will support execution of clinical studies to support product development and validation while building strong relationships with clinical trial sites
- You will collaborate cross-functionally to ensure on-time monitoring, audit-readiness both at sponsor and sites, and will contribute to study reports and regulatory submission deliverables
- You will collaborate effectively with peers and leadership across departments and professionally interact/build relationships with Investigators and site staff, Institutional Review Boards (IRBs), and key opinion leaders
- You will develop study documentation, perform site selection/qualification, train and support sites in study procedures, monitor study compliance, study closeout, and other activities related to study operations
- You will coordinate with monitors and data management to ensure data quality and timeliness
- You will contribute to process improvements across all aspects of clinical study operations
Skills
- Ability and judgement to work under minimal supervision to plan and execute site study operations, including on-site and remote training & support, requesting and tracking supplies, documentation, training sites and fellow team members, and generating progress reports
- Ability to communicate effectively with site staff, including Principal Investigators, and internal study team members
- Skill and experience at working cross-functionally to achieve goals
- Strong Good Clinical Practice (GCP) and clinical study background, including experience as a CRA; experience in the medical device industry and/or with diabetes is a plus
- Ability to work on multiple studies concurrently and to work with monitors successfully to reduce overall time from last participant on study to database lock while improving site compliance
- Experience with using electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF)
- 15-25%
- 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
- Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
- Preferred experience with Continuous Glucose Monitoring (CGM) Systems
- Preferred experience in diabetes clinical trials involving insulin therapies, insulin pumps, or digital health technologies
Benefits
- 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.
- Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
- If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available.
- Flex workplace option.
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