Intern - Clinical Research Associate 1
About Dexcom:
Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
Throughout the pandemic, one of our key priorities has been to keep employees as safe as possible. At this time, we plan for most of our summer internships to be virtual, with exceptions of essential groups. We ask for our intern candidates to be flexible to a virtual format or residence in the location of the position throughout the duration of the internship.
Position Summary:
Seeking entry level CRA with pharma or medical device experience to work on a high-performing Clinical Affairs team to facilitate Dexcom’s support of external clinical projects. Scope of responsibilities include working with the members of the External-Research team in facilitating Dexcom’s support of external clinical projects {e.g. investigator-initiated studies (IIS), artificial pancreas (AP) studies, and hospital studies}, including assistance with initiation of and ongoing support for external clinical projects. CRA 1 will additionally support CRO partner/distributer forecasts, requests, and facilitate shipments globally.
CRA1 will work collaboratively to monitor incoming research support requests, to track/execute legal documents (e.g. contract/supply agreements), and to provide/fulfill projections and timelines for external project support (e.g. product/training needs). The CRA 1 will ensure project deliverables and financial milestones are fulfilled and tracked (e.g. orders, project funding, etc.). The Clinical Studies CRA-1 will assist in preparing monthly external project reviews as well as surveys/competitive analysis of public trial registry databases (e.g. National Clinical Trials, EU Clinical Trial Register, etc. Additional support duties will include project initiation, training, administrative, and technical support for new and ongoing external research projects.
The ability to manage multiple projects simultaneously in a time sensitive manner is a critical job function.
Duties and Responsibilities:
- Assist in the development of clinical study documents (e.g. training presentations, product supply requests, product requests, etc.).
- Review project details, including protocols, study reports, and other materials for comprehensive support of external trials.
- Support clinical program manager with contract development, legal review and creation of legal study required documents (SLA, MTA, CTSA, LOA, NDA, etc.).
- Provide ongoing administrative and audit support for external research projects/trackers.
- Assist cross-functional interactions with Internal, External and OUS customers when required.
- Deliver on external study timelines and milestones, as required.
- Track, manage and coordinate supply chains, forecasting and shipping for external studies and CRO partners/distributers.
- Review and summarize trial registry data (e.g. ClinicalTrials.gov, EU Clinical Trial Register) maintaining awareness of potential competitive studies and changes in the competitive landscape.
- Provide device support for IIS-AP-HOS external researchers as needed
- Apply best practices in quality, planning, execution, support and closing of external clinical projects, adhering to scope, schedule, budget and regulatory requirements.
- Support Clinical Project Managers in providing Clinical Affairs/External Research Review Board with monthly updates.
- Collaborate effectively with peers and leadership across departments. Professionally interact/build relationships with internal and external key leaders during and throughout projects.
- Functional understanding of the FDA’s Code of Federal Regulation (CFR), Good Clinical Practices (GCP), ICH guidelines, and completion of CITI Ethics training.
- Field support including on-site or webinar training may be required.
- Ability to communicate clearly with internal, external and cross-functional partners – in both written and verbal communications.
- Effectively communicate with multiple CRO partners/distributers recognizing unique contract requirements
Essential Skills:
- Experience in research, science, or medical device field, in-lieu of Bachelor’s degree is accepted
- Knowledgeable about device regulations and how this pertains to sponsor supported Investigator Initiated studies
- Good Clinical Practice (GCP) certification desired
- Professional certification (e.g. ACRP, SoCRA, RAPS) is a plus.
Travel Required:
- Up to 25%