Clinical Research AssociateRequirements: • Must meet all requirements for the Clinical Research Associate position and have demonstrated proficiency in all relevant areas. • Drafts and coordinates review of protocols, informed consents, case report forms, and monitoring plans. • May participate in abstract presentations, oral presentations, and manuscript development. • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. • Ability to develop tools and processes that increase measured efficiencies of the projectTop 3 skills: • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies. • Assists in CRO or vendor selection. With guidance from the supervisor coordinate CROs or vendors.
