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Regulatory Affairs Coord I

February 16, 2026

Location:Remote - TXDepartment:Research OperationsShift:First Shift (United States of America)Standard Weekly Hours:40Summary: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:<ul><li>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</li><li>Computer proficiency in word processing and Excel required</li><li>Knowledge of medical terminology required</li><li>Knowledge of principles of research and federal regulations required</li><li>Detail-oriented with strong organizational skills</li><li>Excellent writing and editing skills</li><li>Good interpersonal and communication skills required</li><li>IRB Administration or Clinical Research certification required if used in lieu of education</li><li>Prefer 2 years’ experience in clinical research regulatory affairs, including oversight of investigator-initiated and industry-sponsored trials</li><li>Ability to support the life cycle of investigator-initiated research projects</li><li>Working knowledge of FDA regulations and guidance, including IND, IDE, and amendment submissions</li><li>Proactive problem-solving skills to resolve issues to support endowed chair’s mission</li></ul>About Us: Cook Children's Health Care SystemCook 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.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...