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Administrative Assistant-Pharma/Healthcare - Spanish

Company: Careerbuilder-US
Location: Hollywood
Posted on: November 19, 2021

Job Description:

Title: Administrative Assistant-Pharma/Healthcare - Spanish Location: Miramar FL 33025 Type: Contract W2 Duration: 6+ Months (Possible extension) 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 I 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.. Please ensure you are willing to begin at a more administrative role. 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 strictcompliance to the study protocol at all times Generates, facilitates and maintains all study related regulatory documents from prestudythrough 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 Qualifications: Education a Bachelor's Degree in a health field is required. Job Requirements: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: Careerbuilder-US, Hollywood , Administrative Assistant-Pharma/Healthcare - Spanish, Administration, Clerical , Hollywood, Florida

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