Regulatory Affairs Coord I

Cook Children's Health Care System

1d • Remote

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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
• audit participation

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level