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Job #02666

About our client Our client is a rapidly growing pharmaceutical company headquartered in Southern California that is focused on the development and commercialization of various therapeutics for dermatology. The company has an experienced CEO, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Senior Clinical Research Associate (Home-Based) USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor (pre-study, initiation, routine and close-out 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) Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites 4) Review draft protocols for completeness and feasibility 5) Develop CRFs for clinical trials 6) Prepare and process Serious Adverse Event (SAE) reports 7) Resolve queries of CRF data with study site personnel 8) Review tables and listings generated from study data Requirements 1) BS 2) Minimum 5 years of CRA experience in monitoring clinical trials from qualification to closeout 3) Experience in monitoring dermatology trials preferred 4) Strong knowledge and understanding of FDA regulations and GCPs 5) Exceptional interpersonal and communication skills 6) Strong problem-solving skills