Description
Responsibilities* Maintaining of the Clinical Trial Master Files (CTMFs) by filing all documents in the study files both electronically and hard copy.
* Set up CTMFs for new sites or studies, both hard copy and electronic.
* Track essential regulatory documents from Investigators/clinical sites and request updates when needed (such as expired documents, etc.)
* Review files for completeness and accuracy
* As needed, assist in packaging and shipping of supplies to study sites.
Qualifications
Experience with Dermatology, Ophthalmology or Urology clinical studies is highly desirable.
* 4-year college degree
* Understanding of FDA guidelines, ICH and GCPs and ability to attain and maintain a working knowledge of applicable SOPs
* Basic computer skills and ability to learn and become proficient with appropriate software
* Effective organizational skills and strong attention to detail.
* Minimum of two years of experience managing clinical study files.
To find out more about Real please visit www.realstaffing.com