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Search for Jobs by Diane Brescia

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Clinical Study Associate  (Science & Biotech)
Irvine , CA 92606
Recruited by: Diane Brescia | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Science & Biotech
  • Compensation: To Be Determined
  • Expires: Jun 13, 2019
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Job Description

• Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
• Creation/distribution of regulatory binders & the wet-ink signed documents binder
• Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
• Assist in providing internal communication of important clinical data and events.
• Support ongoing use of CTMS by maintaining and tracking relevant activities.
• Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).

Education
• Minimum of a Bachelor’s Degree is required.

Experience
• Previous clinical research experience a plus.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background a plus.