Description
Duties:The Sr. CRA is responsible for administering clinical trial activities. This position assists with performing in-house study management responsibilities, traveling to clinical sites to perform monitoring and site management responsibilities, ensuring site performance and adherence to the protocol, company procedures, local, state, GCP/ICH, FDA, and other required regulations and guidelines. Responsibilities include clinical site management, collecting and tracking study documentation, tracking study costs, and development of study-related documents.
Requirements:
Bachelor's degree preferably in the Life Sciences or health-related field and a minimum 3-4 years as a study monitor (depending on education/related experience) plus experience assisting with in-house study management in a clinical research environment
Knowledge of ISO 13485:2003, US FDA QSR, ICH and other system requirements relating to the Medical Device Industry. Must be a team player, have strong communication skills, organization skills, strong computer literacy and the ability to travel 30% of the time.
To find out more about Real please visit www.realstaffing.com