US-NJ, Regulatory Document Specialist 1455-MZ
ExecuPharm has an opening for a Regulatory Document Specialist working on Novartis studies based out of their East Hanover, NJ location.
- Bachelor Degree preferred or equivalent experience
- Heavy emphasis on the ability to review Informed Consent Form language by comparing against Novartis template language.
- Experience negotiating standard template language with local sites, as appropriate.
Ability to work independently and in a team environment to ensure timely trial initiation. Responsible for reviewing regulatory documents for accuracy and completeness; communicates with investigator/study sites on document updates/corrections; liaises with Field Monitor on trial documents and start up activities; liaises with Informed Consent Management group on informed consent/IRB approval; manages and tracks submission of documents prior to drug shipment; responsible for scanning and importing documents into Novartis archive repository.
· Prepares start-up package, uploads start-up documents to Novartis Portal, submits the regulatory documents to the Central IRB
· Reviews Informed Consent Form language by comparing against Novartis template language. Negotiate standard template language with local sites, as appropriate.
· Works closely with Contract Manager to ensure coordination of activities and timely start-up
· Reviews incoming documents for accuracy and completeness
· Contact sites on an ongoing basis to expedite collection process and tracks collection progress
· Works with sites to answer questions and ensure necessary corrections and revisions are made
· Updates database in real time to reflect received documents and site comments
· Coordinates central IRB submissions
· Prepares Verification of Document Receipt (VDR) form once all requirements have been met
· Scans and imports all essential VDR documents into Novartis CREDI repository, sends hard copies to Document Management
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