Clinical Research Associate/CRA (West Coast)

Title:  Clinical Research Associate

Country United States (West Coast)

Description Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to SOPs and/or client guidelinesRecruit investigators for participation in clinical trialsNegotiate study budgets with investigatorsObtain, review for appropriateness, and process regulatory and administrative documents from investigator sitesReview draft protocols for completeness and feasibilityDevelop Case Report Forms for clinical trialsPresent (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ MeetingsPrepare and process Serious Adverse Event (SAE) reports Prepare project management reports for clients, project personnel, and managementReview and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queriesResolve queries of CRF data with study site personnelReview Tables and Listings generated from study data Assist in writing Clinical Study Reports, with supervision

 

Requirements Bachelor’s degree or RNTwo years work experience in clinical research, data management, regulatory affairs or other relevant healthcare research position. In lieu of this work experience, those with an applicable doctoral degree (eg, PhD, PharmD, MD) will be consideredEffective written and verbal communication skillsAbility and willingness to travel up to 50%Excellent organizational skillsAbility to manage time and work independently

 

** Must have experience in one of the following therapeutic areas: Oncology, Neuroscience, Cardiovascular, or Infectious Disease**