Clinical Research Regulatory Coordinator I

Johns Hopkins Medicine•Saint Petersburg, FL

42d•$25 - $40

About The Position

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.

Requirements

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
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

Responsibilities

Ensuring that accurate and upto-date regulatory files are maintained for all pediatric clinical research studies.
Serving 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
Coordinating the submission of initial Institutional Review Board (IRB) applications for complex clinical research studies.
Preparing all regulatory binders prior to the start of each study, containing IRB-approved initial documents and sections for all required documents all.
Ensuring that all applicable changes in study design and/or conduct, and all continuing reviews, are submitted to the IRB in a timely manner.
Updating the study team on IRB approval status of submitted study changes and continuing reviews.