Regulatory Affairs Coordinator I

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 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.

Certification/Licensure:

• IRB Administration or Clinical Research certification required if used in lieu of education.

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 EOE/AA, Minority/Female/Disability/Veteran employer.