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Job #02623

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 New York/New Jersey, Toronto/Montreal Salary Highly competitive package, commensurate with experience Responsibilities 1) Meet established schedules and prioritize tasks as well as time to meet those schedules (understanding the urgency of tasks) 2) Identify and select trial sites 3) Conduct qualification, initiation, interim-monitoring closeout visits and perform drug accountability 4) Ensure the 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 the preparation of investigator’s meetings 8) Maintain current knowledge of all 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) Ensure that the assigned studies adhere to approved protocols 11) Maintain a level of accuracy that minimizes data query rate 12) Ensure that the data are accurately transcribed to meet SOP and audit expectations 13) Identify and provide solutions for data trends Requirements 1) BA or BS with 1+ years of experience in a clinical research environment 2) Experience in oncology and urology preferred 3) CRA (home-based) and monitoring experience preferred 4) Fundamental understanding of clinical research 5) Knowledge of relevant SOPs 6) Working knowledge of MS Word and Excel along with in-depth knowledge of other presentation programs a plus 7) Strong attention to detail with an ability to prioritize 8) Self-directed and motivated (preferred) 9) Ability to work well under pressure with tight schedules 10) Ability to plan and schedule workload and work effectively with others 11) Ability to exercise judgment within generally defined practices and policies for obtaining data 12) Ability to resolve problems positively and professionally 13) Strong, organizational planning, and follow-through skills 14) Excellent language and grammar skills 15) Superior communication, interpersonal, and organizational skills in addition to the technical skills for overseeing clinical studies 16) Willingness to travel – up to 50%