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Sr. CRA: MedFocus

Job ID0000068173
Company NameMedFocus
Job CategoryPharmaceutical/Biotech; Other
LocationSanta Clara, CA
Position TypeFull-Time, Contract
Experience5-10 Years Experience
Desired Education LevelBachelor of Science
Date PostedOctober 8, 2009

Sr. CRA

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

Our client is a global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health and is seeking to add a Sr. CRA to their team in Santa Clara, California.

RESPONSIBILITIES:
• Ensure timely collection of all clinical study documents
• Maintain and control all necessary records
• Ensure compliance with protocol and all regulations, policies, procedures and guidelines during clinical study by training/guiding investigators and study coordinators
• Oversee up to 25 clinical sites through follow up phase and protocol amendments

QUALIFICATIONS:
• Minimum of 5 years experience as a CRA, preferably in the Medical Device field
• Experience in review of study regulatory documents, informed consent review and approval for protocol amendment changes, study contract budget negotiations and management of compliance at study sites
• Ability to function within a team
• Able to manage individual site issues without oversight
• Experience with electronic data capture system(s)
• Experience with electronic document management system(s)

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.



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