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4 days old

Regulatory Coordinator

Kelly Services
Tulsa, OK 74152
**Regulatory Coordinator**





Kelly Services is currently seeking a **Research Regulatory Coordinator** for one of our top clients in Healthcare in the **Tusla, Oklahoma** area. The Regulatory Coordinator will work under minimal supervision and coordinate the research and administrative activities of clinical trials for the company by managing Regulatory procedures.







**Responsibilities:**






+ Maintains protocol regulatory documents in compliance with company

+ Maintains protocol regulatory documents for compliance with the review board including renewals, changes to open protocols, and submission of new protocols for assigned studies.

+ Participates in and supports all site auditing and monitoring visits related to trials.

+ Communicates, reviews, and documents Regulatory Memoranda with physicians and other clinical staff as appropriate.

+ Assists in the development and implementation of policies and procedures for regulatory documentation functions.

+ Actively participates in protocol initiations and study specific educational programs. Communicates and collaborates on ongoing basis with central operations and data management.

+ Presents, compiles, and maintains documents needed for Institutional Review Board (IRB), Food and Drug Admission submissions.

+ Maintains regulatory files by filing and auditing existing regulatory documentation prior to regularly scheduled monitoring visits and audits.

+ Prepares regulatory documentation packets and creates all FDA 1572 forms for sponsor submission if required for assigned studies.

+ Compiles information necessary for continuing review by IRBs and FDA, if required for assigned studies.

+ Assists other Regulatory staff as back-up on pharmaceutical studies as needed.

+ Participates in and supports all site auditing and monitoring visits





**Qualifications:**




+ High School Diploma or equivalent (Associates or bachelors degree preferred)

+ Minimum of one to three years experience in office setting (preferably medical)

+ Computer proficiency in Microsoft Office products including MS Word, Excel, and PowerPoint.

+ CCRP certification preferred, but not required

+ Knowledge of OCSRI policies and procedures

+ Knowledge of current FDA regulations, and Good Clinical Practices, governing clinical research,






















**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-09-14 Expires: 2020-10-15

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Regulatory Coordinator

Kelly Services
Tulsa, OK 74152

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