QC Reviewer (440754)
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OVERVIEW:QC Review of Submission Documents (need to have experience sitting with documents and cross referencing to ensure consistency) Content QC: Review of actual content, not just formatReview References (must have experiences reviewing references to make sure articles are in the documents) Performing QC using MULTIPLE Vendors (candidate will be responsible for managing calendar to ensure vendors are meeting timelines for document review and reviewing the work to ensure it is done accurately) Review Comments (make sure they are acceptable and that they make sense) Job Duties: Independently conduct QC reviews of on a variety of GCP related study documents (e.g; CSRs/CSR Amendments, Protocols/Protocol Amendments, IBs, NDA submissions documents) according to Client's processes and applicable regulatory requirements; provide detailed written QC review comments Strong working knowledge and experience (approximately 2-3 years) in independently conducting QC review activities on a variety of GCP related study documents (e.g; CSRs/CSR Amendments, Protocols/Protocol Amendments, IBs, NDA submissions documents) Assist with maintaining internal Document QC schedule and applicable electronic internal files Communicate with QC Vendors on the scheduling and sending of document for QC review, questions, and providing feedback on results Assist in maintaining document QC metrics Communicate with Medical Writing and other functional areas regarding the results and resolution of the Document QC review comments. Strong written and communication skills, and detail oriented
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