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Job #02883

About our client Our client is a global, publicly traded drug development services company, headquartered in New Jersey. The company has exceptional financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Clinical Research Associate (Home-Based) California Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor (pre-study, initiation, routine and closeout visits) at investigator sites for GCP compliance according to company SOPs and client guidelines 2) Generate study-specific documentation, including monitoring trip reports, telephone contact reports, site correspondence and expense reports 3) Recruit investigators for participation in clinical trials 4) Conduct project feasibility assessments 5) Negotiate study budgets with investigators 6) Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites 7) Review draft protocols for completeness and feasibility 8) Develop CRFs for clinical trials 9) Participate in Investigator meetings (e.g. study specific guidelines and procedures, CRFs and monitoring conventions) 10) Prepare and process SAE reports 11) Resolve queries of CRF data with study-site personnel 12) Prepare project management reports for clients, project personnel and management 13) Review tables and listings generated from study data Requirements 1) Bachelor’s degree or RN 2) Minimum 3 years of CRA experience in monitoring clinical trials (from qualification to closeout) with expertise in site management 3) 2 years of recent oncology experience 4) Ability to manage time and work independently 5) Excellent organizational skills 6) Superb communication skills (written and verbal) 7) Willingness to travel overnight – up to 60%