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Job #02773

About our client Our client is a rapidly growing pharmaceutical company headquartered in Irvine, California that is focused in the acquisition, development and commercialization of oncology and urology therapeutics. Position Location Regional Clinical Research Associate – Texas Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Demonstrate superior communication and organizational skills in addition to technical skills required for overseeing clinical studies 2) Recognize the urgency of meeting established schedules with prioritizing tasks and time to meet those schedules 3) Assist with identifying and selecting trial sites, conduct qualification, initiation, interim monitoring closeout visits as well as performing drug accountability 4) Ensure timely collection of appropriate regulatory documents from study sites 5) Assist in the development of materials that support the conduct of clinical studies, including site reference manuals, monitoring flow sheets, CRF completion guidelines, etc. 6) Review clinical documents for accuracy and completion (1572, consents, protocols, meeting minutes, etc.) 7) Assist in preparing Investigator’s meetings 8) Maintain current knowledge of applicable regulations concerning development and conduct of human clinical trials (CFRs, ICH) 9) Communicate to investigators the rudiments of GCP and their related tasks 10) Demonstrate working knowledge of relevant clinical trial SOPs 11) Ensure that assigned studies adhere to approved protocols 12) Maintain a level of accuracy that minimizes data query rate and ensures that data are accurately transcribed to meet SOP and audit expectations 13) Identify and provide solutions for data trends Requirements 1) BA or BS degree with minimum 1-year in the clinical research environment 2) Home-based CRA experience with a ready office setup 3) Experience in monitoring 4) Fundamental understanding of clinical research 5) Working knowledge of relevant SOPs 6) Good interpersonal and communication skills with the ability to establish professional working relationships with colleagues and site personnel 7) Familiarity with MS Word, Excel and in-depth knowledge of other presentation programs a plus 8) Strong, organizational, planning and follow-through skills 9) Ability to resolve problems positively and professionally 10) Good attention to detail with the ability to prioritize 11) Ability to work well under pressure as well as with tight schedules 12) Self-directed and motivated 13) Ability to exercise judgment within generally defined practices and policies for obtaining data 14) Ability to plan and schedule workload and work effectively with others 15) Excellent language and grammar skills with the ability to write clearly and concisely 16) Willingness to travel – up to 50%