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Regulatory Affairs Associate I

Company: Cogent Infotech Corporation
Location: Miramar
Posted on: November 14, 2022

Job Description:

--- Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times
--- Generates, facilitates and maintains all study related regulatory documents from prestudy through study close out, ensuring quality, accuracy, and timeliness
--- Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements
--- Prepares and maintains records for archiving and/or retrieval
--- Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits.
--- Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues
--- Provides administrative and operational support to internal departments and clinical management teams
--- Proficient in MS Office (Word, Outlook, Excel and Teams)
--- Experience organizing documents, Trial Master File preferred, in a health environment
--- Minimum of three (3) years of experience in the supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession medical device company, or as a clinical research coordinator at an investigative site


Keywords: Cogent Infotech Corporation, Hollywood , Regulatory Affairs Associate I, Other , Miramar, Florida

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