Clinical Research Regulatory Coordinator I

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YOU BELONG HERE

What Awaits You?

• Career growth and development
• Employee and Dependent Tuition Assistance
• Diverse and collaborative working environment
• Affordable and comprehensive benefits package

• Our competitive Benefit Package is designed to support the well-being and financial security of our employees. You can explore the details of our benefits offering by visiting the following link Johns Hopkins All Children's Hospital | Your benefits virtually (mybenefitsjhhs.com)

Summary:

The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and upto-date regulatory files are maintained for all pediatric clinical research studies. This person will serve as a central resource for faculty conducting interventional and non-interventional clinical and translational research. Working closely with the Study Start Up Manager, Clinical Research Managers and study teams, this person will coordinate the submission of initial Institutional Review Board (IRB) applications for complex clinical research studies. In addition, the coordinator will prepare all regulatory binders prior to the start of each study, containing IRB-approved initial documents and sections for all required documents all. This individual will also work to ensure that all applicable changes in study design and/or conduct, and all continuing reviews, are submitted to the IRB in a timely manner. The incumbent will also update the study team on IRB approval status of submitted study changes and continuing reviews.

Qualifications

Either one of the following is required:

• Bachelor's degree
• 2 years of clinical research experience equivalent healthcare experience with knowledge of regulatory and/or study startup process OR

• Associate's degree
• 6 years of experience in clinical research / equivalent healthcare experience with knowledge of regulatory and/or study startup process

Other qualifications:

• Computer proficiency in using Microsoft Office including Word, Excel, and Outlook
• Ability to communicate effectively, both verbally and in writing; ability to read, write, speak and understand English
• Excellent organizational and time management skills
• Motivated, organized, personable, willing to learn, responsible, reliable, and efficient

Salary Range: Minimum 24.95/hour - Maximum 39.92/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.

We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.

Johns Hopkins Health System and its affiliates are drug-free workplace employers.