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.