Job Description

Position: Clinical Research Associate III , Req#: ISIJP00010853

Location: Sunnyvale, CA (100% Onsite Only).

Duration: 12+ Months Contract

Job Description:

Required Education and Training

• Typically requires a minimum of 8 years of related experience with a BA/BS university degree; or a minimum 6 years' experience and a Nursing degree, a Master's degree, or an MD or PhD with a minimum 3 years' experience; or equivalent experience in a scientific field.

Primary Function of the Position

• The Senior Clinical Research Associate will play a key role in proactively helping with the conduct of pre-market and post-market clinical studies to ensure compliance with all regulatory requirements.
• The ideal candidate will have a thorough knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, and other applicable regulations. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies (pre-market or post-market studies) with minimal supervision.
• The candidate will be required to work closely with clinical study managers, clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, contribute to clinical study reports, or help the development of clinical publications. The candidate is also expected to have experience reviewing, interpreting, and summarizing clinical literature.

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