Clinical Research Associate II

JOB DESCRIPTION:

The Opportunity:

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As the Clinical Research Associate II, you will assist in the clinical execution and management of assigned clinical studies. This includes but is not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. You will also present clinical study opportunities to potential research sites and evaluate their ability to conduct ADC research studies.

What you will do:

• Participate in site selection and study start up activities, to include but not limited to, conducting investigator debarment checks, collection of regulatory documents and preparing the study files.
• Conduct Site Qualification Visits (SQV) and reporting to ensure study staff and research site are adequate to perform ADC trials.
• Present research protocols with a deep understanding of study criteria, visits, tasks and responsibilities.
• As needed, assist senior staff in planning study conduct,  selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
• Assist in the shipment of study devices and supplies to clinical sites and performing study device accountability.
• Maintain and audit Trial Master File to ensure inspection readiness.      
• Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
• Proactively and effectively communicate the status of clinical studies to management. 
• Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
• May interact with RA/QA in responding to audits and FDA inquiries.
• May be asked to perform other function-related activities in addition to the activities above.

Education and Experience

• BS degree in life sciences with three years of experience as a CRA or CRC or combination of appropriate education and experience.
• Preferred to have 3+ years of relevant experience in frequent sample testing studies, site monitoring, clinical trial practices and regulations.
• Experience in conducting medical device and/or in-vitro diagnostics studies.  Pharmaceutical background may also be considered.

Skills

• Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Ability to understand and articulate complex study designs and requirements to investigators and study staff.
• Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
• Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite.

Travel Requirements

• Must be able to travel 10-15%

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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