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Job #02663

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 - Pacific Northwest Pacific Northwest (Ideally WA) Salary Highly competitive package, commensurate with experience Responsibilities 1) Meet established schedules along with prioritizing tasks and time to meet those schedules 2) Identify and select trial sites 3) Conduct qualification, initiation, interim-monitoring closeout visits along with performing drug accountability 4) Ensure timely collection of appropriate regulatory documents from study sites 5) Assist 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) Remain current with applicable regulations concerning development and conducting human clinical trials (CFRs, ICH) 9) Communicate to investigators the rudiments of GCP and their related responsibilities 10) Ensure assigned studies adherence to approved protocols 11) Maintain a level of accuracy that minimizes data query rate 12) Ensure that the data are accurately transcribed 13) Meet SOP and audit expectations 14) Identify and provide solutions for data trends Requirements 1) BA or BS degree with 1+ years of experience in a clinical research environment 2) Experience in oncology and urology preferred 3) Understanding of clinical research 4) Knowledge of the relevant SOPs 5) MS Word, Excel and in-depth knowledge of other presentation programs a plus 6) Attention to detail and ability to prioritize 7) Self-directed and motivated 8) Ability to work well under pressure and with tight schedules 9) Ability to plan and schedule workload and work effectively with others 10) Ability to resolve problems positively and professionally 11) Ability to exercise judgment within generally defined practices and policies for obtaining data 12) Ability to write clearly and concisely 13) Excellent interpersonal and communication skills to establish professional working relationships with colleagues and site personnel 14) Strong organizational planning and follow-through skills 15) Excellent language and grammar skills 16) Superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies