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| Job #02662 |
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| 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 – Chicago |
Illinois |
| 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 and interim-monitoring closeout visits along with performing 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) Remain current with applicable regulations concerning development and conduct human clinical trials (CFRs, ICH) 9) Communicate to investigators the rudiments of GCP and their related responsibilities 10) Ensure that assigned studies adhere to approved protocols 11) Maintain a level of accuracy that minimizes data query rate and ensure that data are accurately transcribed to meet SOP and audit expectations 12) 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) Strong organizational, planning and follow-through skills 6) Good attention to detail and ability to prioritize 7) Self-direction and motivation 8) Ability to resolve problems positively and professionally 9) Superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies 10) Ability to exercise judgment within generally defined practices and policies for obtaining data 11) Excellent communication skills to establish professional working relationships with colleagues and site personnel 12) Ability to write clearly and concisely 13) Excellent language and grammar skills 14) Ability to work well under pressure and with tight schedules 15) Ability to plan and schedule workload and work effectively with others 16) MS Word, Excel, in-depth knowledge of other presentation programs a plus |

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