POSITION SUMMARY:

The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up-to-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, s/he 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. S/he will also update the study t...