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13 days old

Regulatory Affairs Specialist _ Miramar, FL

Kelly Services
Miramar, FL 33027
**Regulatory Affairs Specialist Miramar, FL**





Kelly Services is currently seeking a Regulatory Affairs Specialist for one of our top clients in Miramar, FL.





**Shift:** days / Mon-Fri



**Length of the assignment:** 3 - 6 moths



**Pay rate:** $15/hr - $22/hr





**Mgr is okay with a person who does not have experience just as long as the person is willing to learn and follow our process.





**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 pre-study 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





**Qualifications:**




+ Education a Bachelor's Degree in a health field is required. Bachelors Preferred but not required with office experience or regulatory 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

+ Bilingual read/write in Spanish/English





Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.





Why Kelly?




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*







Apply Today!





*Available for purchase and administered by a designated third-party vendor




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2021-01-11 Expires: 2021-02-11

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Regulatory Affairs Specialist _ Miramar, FL

Kelly Services
Miramar, FL 33027

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