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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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 Job #02664 Email this job to a friend
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 Chief Executive Officer, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Position Location
Clinical Research Associate Southern 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) Obtain regulatory, process and administrative documents from investigator sites and review for appropriateness
4) Review draft protocols for completeness and feasibility
5) Develop CRFs for clinical trials
6) Prepare and process reports for serious adverse advents
7) Resolve queries of CRF data with study site personnel
8) Review tables and listings generated from study data
Requirements
1) BS degree
2) 2+ years of CRA experience in monitoring clinical trials from qualification to closeout
3) Experience in monitoring dermatology trials preferred
4) In-depth knowledge and understanding of FDA regulations and GCPs
5) Superb interpersonal and communication skills
6) Strong problem-solving skills

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