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 Job #02662 Email this job to a friend
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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