The Document Specialists primary responsibility will be establishing, maintaining and archiving a filing system that supports the Trial Master File (TMF) in accordance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and CNS (SOPs).
Requirements:
“ Experience in a medically related profession or a pharmaceutical or medical device company or as a clinical research coordinator at an investigative site
Education
“ Minimum of Bachelor Degree in Health Related Field
“ Combination of college education, training and experience that provides the knowledge, skills and abilities to perform the job in lieu of Bachelor’s degree
Minimum Work Experience
“ Experience in organizing documents, TMF preferred, in a health care environment
“ Minimum three (3) experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity. Has demonstrated thorough knowledge of the operational aspects of pharmaceutical studies.
This is a three month temporary assignment. Car necessary to reach location.
If qualfied and interested please forward your resume to: JillR@AplusPersonnel.com