Regulatory Affairs Associate in Miramar, FL
- Title: Regulatory Affairs Associate
- Code: RCI-8508
- RequirementID: 105341
- Location: Miramar, FL 33025
- Posted Date: 01/25/2023
- Duration: 6 Months
- Salary ($): 20.38 - 21.68 per Hourly
- Name:Rajgurusingh Azad
- Email: Rajgurusingh.email@example.com
- Phone: 908-704-8843 ✖ 225
Shift/days/ some weekends Mon-Fri
Length of the assignment 6 months with certain extension for right candidate
Bachelors Preferred but not required with office experience or regulatory experience .
Mgr seeking Long Term Candidate as there is a lot of training involved.Admin type role, candidate will be trained on Regulatory affairs. Must be bilingual to review documents in Spanish and verify no errors in English. Basic Excel and Word skill, and be fluent with Outlook (reading, organizing and writing emails).
This role would start out more as an administrative assistant type of work (filing, scanning, printing and filing, reading and compiling emails, creating documents, gathering signatures, reviewing and comparing Spanish documents). 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..
The Regulatory Affairs Associate 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).
- Bilingual read/write in Spanish/English.
- Attach a test showing basic understanding of Excel, Word, Outlook
- 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 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
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