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15 days old

Clinical Research Regulatory/IRB

Kelly Services
Richardson, TX 75081
Clinical Research Regulatory/IRB Richardson, TX


Kelly Science & Clinical is currently seeking a Regulatory/IRB for one of our top clients in Richardson, TX.


This role is responsible for overseeing area of specialty as it relates to clinic operations and study conduct.


Job Responsibilities:


+ Support Regulatory Affairs Specialist by preparing technical documents for country specific needs, product registration documents, etc.

+ Assist with maintaining product files, product certifications, etc and updating them in Ensur and performing yearly documentation review.

+ Assist with preparing special documentation, per request, for countries that have problems releasing a shipment, if needed.

+ Prepare technical documents to support a country with registration needs or consumer requests/complaints.

+ Prepare special documents per request from the Regulatory Affairs Specialist that require legalization and send via Federal Express or USPS (as appropriate) to the appropriate Consulates General.

+ Assist with regulatory document submissions to IASC, IFANCA, the Halal certifying agency, and to the Rabbi for initial certifications and certification renewals.

+ Request Certificates of Free Sale from the Texas Department of State Health Services.

+ Order Certificates of Authentications and Apostilles from the Texas Secretary of State.

+ Complete a Health Certificate, Export Certificate, Animal Products VS Form 16-4 form to order Export Certificates from the United States Department of Agriculture.

+ Archive electronic e-mails and scanned documents into designated archiving drive.

+ Prepare all required documents using Word, Excel and e-mail.

+ Prepare all documents for foreign countries in English.

+ Remain calm and pleasant in handling all problems.

+ Work efficiently to meet all deadlines and respond timely to all requests.

+ Work cooperatively with co-workers and supervisors.

+ Maintain regular and punctual attendance at work.

+ All other duties as assigned.


Job Requirements:


+ Bachelors degree, preferably in Science or equivalent degree and over 3 years of clinical research experience OR minimum 1 year of clinical research

+ CCRC or CCRA certification preferred

+ Previous IRB submission experience

+ Ensure compliance with regulations

+ Strong attention to detail and organizational, verbal and written communication and interpersonal skills

+ Understands specific concepts clinical assessment techniques and/or procedures in clinical research and capable of learning and performing duties related to area of specialization

+ Able to apply knowledge of GCP guidelines, applicable regulations, SOPs, Work Instructions and Sponsor Specific procedures

+ Able to utilize all bioinstrumentation techniques

+ Capable of coordinating the IRB submission and regulatory compliance of multiple complex studies at once


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-04-05 Expires: 2021-05-06

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Clinical Research Regulatory/IRB

Kelly Services
Richardson, TX 75081

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