QC Reviewer (440754)

This job is no longer active. View similar jobs.

POST DATE 9/13/2016
END DATE 10/11/2016

Advanced Clinical Edison, NJ

Company
Advanced Clinical
Job Classification
Full Time
Company Ref #
040e20541
AJE Ref #
576166472
Location
Edison, NJ
Experience
Mid-Career (2 - 15 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Job Description:

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

Company Description:

Contract & Direct-Hire Opportunities with Client Companies

Let Advanced Clinical help you find a career in the clinical research industry! We have built strong relationships with client companies and can match your talents with the right clinical research jobs.