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Job #02775

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 – South North Carolina, South Carolina, Florida, Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist in identifying and selecting trial sites 2) Conduct qualification, initiation and interim monitoring closeout visits 3) Perform drug accountability 4) Ensure timely collection of appropriate regulatory documents from study sites 5) Assist in developing materials that support the conduct of clinical studies (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 meetings 8) Remain current with applicable regulations concerning development and conduct of human clinical trials (CFRs, ICH) 9) Communicate to investigators the rudiments of GCP and their related responsibilities 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 data are accurately transcribed to meet SOP and audit expectations 13) Identify and provide solutions for data trends 14) Demonstrate superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies 15) Focus on meeting established schedules and prioritize tasks to meet the schedules Requirements 1) BA/BS 2) Minimum 1 year of experience in a clinical research environment 3) Home-based CRA experience with ready office setup 4) Experience in monitoring 5) In-depth understanding of clinical research 6) Working knowledge of relevant SOPs 7) Excellent interpersonal and communication skills to establish professional working relationships with colleagues and site personnel 8) Strong organizational, planning and follow-through skills 9) Excellent language and grammar skills with ability to write clearly and concisely 10) Ability to work with MS Word and Excel (in-depth knowledge of other presentation programs a plus) 11) Ability to work well under pressure and with tight schedules 12) Ability to plan and schedule workload as well as work effectively with others 13) Ability to exercise judgment within generally defined practices and policies for obtaining data 14) Ability to resolve problems positively and professionally 15) Attention to detail and the ability to prioritize 16) Self-directed and motivated 17) Willingness to travel – up to 50%