Regulatory Affairs Coord II

Regulatory Affairs Coord II page is loaded## Regulatory Affairs Coord II locations:
Remote - TXtime type:
Full time posted on:
Posted Todayjob requisition :
JR-115670
*
* Location:

** Medical Center Office Building (901 7th Ave)
** Department:
** Research Operations
** Shift:
** First Shift (United States of America)
** Standard Weekly

Hours:

** 40
*
* Summary:

** The Regulatory Affairs Coordinator II possesses substantial clinical research and regulatory knowledge; is capable of independent action in the development, application and maintenance of all regulatory documentation and activities within the Cook Children's System. This person may rely upon other Senior Regulatory Affairs staff for guidance, but is capable of managing a project with highest quality throughout its lifecycle. The Regulatory Affairs Coordinator II will further develop their knowledge of regulatory guidelines through independent study and external training, as appropriate.

*
* Qualifications:

*** Bachelor's degree in appropriate field (e.g., healthcare, social or health science, etc.) and minimum 5 years relevant clinical research, pharmaceutical or regulatory experience with at least 3 years regulatory affairs experience required; or an equivalent combination of education/certification and experience from which comparable knowledge and abilities can be demonstrated
* Computer proficiency in word processing and Excel required
* Knowledge of medical terminology required
* Knowledge of principles of research and federal regulations required
* Detail-oriented with strong organizational skills
* Excellent writing and editing skills
* Good interpersonal and communication skills required
* IRB Administration or Clinical Research certification required if used in lieu of education
** Cook Children's Health Care System
** Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents.

Cook Children’s is an equal opportunity employer. As such, Cook Children’s offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.

Promise, a strong word with deep meaning that everyone understands—especially kids. This is the foundation of our organization and what drives us to blaze new trails in medical care, research, advanced technology, as well as programs and initiatives that benefit children who may not otherwise have access to quality health care. Every day our employees come to work with the intention of keeping our Promise.

It's the guiding principle that helps our patients and their families get better and stay healthy. As a member of our Cook Children's team, you can be an important part of making that happen.
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