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Administrative Assistant

Company: LanceSoft Inc
Location: Miramar
Posted on: November 22, 2021

Job Description:

Job Description

Title: Administrative Assistant - Regulatory
Location: Miramar, FL 33025
Duration: 6 Months

Shift/days/ some weekends Mon-Fri
Length of the assignment 6 months with possible extension

Required :
bilingual read/write in Spanish/English.

This role would start out more as an administrative assistant type of work (filing, printing emails, creating documents, gathering signatures, reviewing Spanish forms). Once all of these tasks are self-managed well then, we would assign and move the individual into more in-depth Regulatory work (with additional training of course) like drafting/QC ICFs/protocols, gathering/uploading documents into our eTMF cloud-based repository, submitting studies to the IRB, etc.

Bachelors Preferred but not required with office experience or regulatory experience.

Job Summary:
The Regulatory Affairs Specialist is responsible for establishing, maintaining, and
providing administrative management of the Regulatory Documents in accordance with
federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard
Operating Procedures (SOPs).

Essential Functions 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 Sponsorrequirements
Prepares and maintains records for archiving and/or retrieval
Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority
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

Education a bachelor's degree in a health field is required.

Experience Experience organizing documents, Trial Master File preferred, in a health environment
Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site

Keywords: LanceSoft Inc, Hollywood , Administrative Assistant, Administration, Clerical , Miramar, Florida

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