Clinical Research Associate
- Expired: over a month ago. Applications are no longer accepted.
The Clinical Research Associate I will be responsible for assisting the overall clinical study conduct of clinical trials to ensure compliance with protocol(s) and Federal regulations, ICH and GCPs, and local requirements.
Duties and Responsibilities include, but are not limited to:
- Assist planning and implementing activities required to manage clinical trials and ensures that Good Clinical Practices (GCP) are followed.
- May act as or site lead for multiple sites simultaneously
- May conduct site visits as required throughout the duration of the study, significant international and domestic travel is anticipated.
- May train clinic sites on proper product use and operation, including hands on training on sensor insertion and removal.
- Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors.
- Support commercialization efforts by assisting in the development of clinical training and education materials related to the use of the product.
- May assist with developing clinical study materials (including but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under direct supervision
Knowledge, Skills, Abilities and Requirements:
- Must have a minimum 4-year undergraduate degree in Natural Sciences or Engineering. Preferred is a graduate degree in same disciplines.
- Must have a minimum of 1 year of applied experience in Clinical Research/Sciences. Preferred experience in implantable medical device industry
- Must be able to travel extensively (including international), many times on short notice
- Well-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiences
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