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Overview

Summary

The regulatory coordinator is responsible for providing high level administrative support to ensure compliance with complex, highly specialized federal, state, local and institutional rules and regulations that govern clinical research studies and trials involving human subjects.

Regulatory coordinators must possess excellent time management and critical thinking skills, have the ability to read and understand complex protocols and accurately complete varying study, sponsor, institutional and IRB specific forms and documentation all of which have varying requirements.

The regulatory coordinator actively participates in the clinical trial throughout it’s lifecycle from initial IRB submission, processing ongoing study amendments or changes, completion of annual continuing reviews, distribution and documentation of protocol amendment training, review, submission and documentation of protocol deviations and serious adverse events, providing initial and ongoing credentialing of all study staff and investigators to the various stakeholders, ensuring delegation logs for each study are complete and up to date, and participating in study monitoring visits and audits.

The coordinator also ensures clinical trial documentation is complete and up to date in multiple spreadsheets, databases and software systems. All of these tasks must be completed within stringent time frames if the clinical trial is to be successful and according to institutional and sometimes federal guidelines for reporting.

Requirements

Minimum:

Minimum of 2 years regulatory experience or 5 years experience as an Administrative Assistant.

Proficient in use of Microsoft Office Suite, Internet Explorer, and general office equipment. Excellent written, verbal and organizational skills. Knowledge of FDA, GCP and ICH guidelines regarding clinical research.

REQNUMBER: 31996