Ardea Biosciences, Inc., a growing biotechnology company in San Diego, is searching for a Contract Clinical Trials Assistant to join the team. Interested parties are encouraged to view the job description and apply on-line at: www.ardeabio.com/careers
The Contract Clinical Trials Assistant will support the efforts of a Phase 1, 2 or 3 clinical operations team, with a heavy emphasis on Phase 1 studies. Responsibilities include, but are not limited to maintaining clinical master files, making investigator payments.
Primary Duties and Responsibilities
Establishes and maintains trial master files (i.e. hard copy and electronic folder set-up, filing, tracking, archiving) in compliance with SOPs, ICH and GCPs.
Prepares study related materials and coordinates distribution to sites.
Reviews site regulatory documents for compliance with ICH GCPs and FDA guidelines and regulations related to clinical trials.
Creates and maintains spreadsheets and timelines for current projects.
Assists in the planning of CRO and study related meetings, participates in teleconferences as needed.
Initiates and tracks confidentiality and consulting agreement request forms as requested.
Provides administrative support, including document preparation and scheduling.
Liaises with individuals within and outside our organization with responsibility for acting independently with minimal oversight.
Participates in team review of data listings and clinical study reports.
Carries out job responsibilities and assignments safely and maintain a clean and safe work area.
Other duties as deemed necessary.
Bachelor’s degree in a scientific discipline or science courses or equivalent experience.
At least 2 years' prior experience working in the bio pharmaceutical industry.
Prior experience with phase 3 and submissions.
Working knowledge of FDA, ICH and GPC regulations and guidance’s and a general knowledge of basic clinical research methods.
Prior experience with electronic document management system(s) (EDMS).
Proficient in standard office applications (MS Word, Excel, PowerPoint).
Well organized and efficient with strong attention to detail.
Apply today at: www.ardeabio.com/careers
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