Regulatory Affairs Coord I

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Summary:

The Regulatory Affairs Coordinator I is new to research regulatory affairs with limited or no regulatory affairs knowledge. May have experience in science, clinical studies or engineering and may understand basic aspects of clinical research. This person is responsible for assisting other regulatory affairs employees with specific tasks including filing, binder preparation and maintenance, basic IRB submissions and communications, essential regulatory document development and maintenance, and audit participation. The Regulatory Affairs Coordinator I will grow their knowledge of regulatory guidelines through ongoing training by internal staff.

Qualifications:

• Bachelor's degree in appropriate field (e.g., healthcare, social or health science, etc.) and 1-year relevant clinical research, pharmaceutical or regulatory 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

• Prefer 2 years' experience in clinical research regulatory affairs, including oversight of investigator-initiated and industry-sponsored trials

• Ability to support the life cycle of investigator-initiated research projects

• Working knowledge of FDA regulations and guidance, including IND, IDE, and amendment submissions

• Proactive problem-solving skills to resolve issues to support endowed chair's mission

About Us:

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.