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 Job #02792 Email this job to a friend
About our client
Our client is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The company has also developed small molecules to treat various other autoimmune and inflammatory conditions.
Position Location
Senior Clinical Research Associate Southern California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Ensure compliance with clinical trials with applicable federal regulations, GCPs, ICH guidelines and the company’s SOPs
2) Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives
3) Represent the company in the global medical research community
4) Develop collaborative relationships with investigational sites
Requirements
1) Bachelor’s degree in a scientific or healthcare discipline
2) 5 years of experience as a CRA in the pharmaceutical or biotechnology industry
3) Experience in conducting pre-study, initiation and closeout visits
4) Experience in working on multinational clinical studies (preferred)
5) Experience in study start-up activities, including the tracking of study-site approval documents
6) In-depth knowledge of FDA CRFs (11, 50, 54, 312 and 3 as well as ICH GCPs
7) Proficiency in Microsoft applications (Word, Excel and PowerPoint)
8) Excellent organizational and communication (written and oral) skills
9) Ability to work with a minimal amount of supervision
10) Willingness to travel (globally) – up to 50%

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