"Alerted.org

Overview

Summary

Responsible for supporting all activities related to the regulatory process as completed by the CTC department. Ensures compliance with regulatory agency regulations and sponsor and departmental standard operating procedures. Works under the supervision of the regulatory manager and performs tasks as assigned. Responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts. Performs other duties as assigned.

Responsibilities

Provides support for the regulatory process from receipt of documents to preparation of all required documents for sponsor and IRB submission.

+ Ensures timely posting, notification and filing of protocol amendments, updates and revisions for all trials.

+ Maintains regulatory binders by ensuring all documents are present and filed correctly.

+ Maintains strict patient confidentiality pursuant to the FDA, GCP and ICH guidelines regarding research subjects.

+ Contributes to a positive work environment and performs other duties as assigned or directed in order to enhance the overall team efforts of the organization.

+ Completes assigned goals.

Requirements, Preferences and Experience

Education

Preferred: Associate Degree preferred

Minimum: Minimum of 2 years regulatory experience or 5 years experience as an Administrative Assistant. Proficient in use of Microsoft Office Suite, Internet Explorer, and general office equipment. Excellent written, verbal and organizational skills. Knowledge of FDA, GCP and ICH guidelines regarding clinical research.

Experience

Minimum: Minimum of 2 years direct experience in clinical research regulatory position or 5 years experience as an Administrative Assistant.

REQNUMBER: 32752