Regulatory Coordinator II Position Available In Shelby, Tennessee

Regulatory Coordinator II

Job ID:

31996

Job Category:

Administrative Non Clinical Support

Work Type:

Full Time

Work Schedule:

Days

Department:

Administration

Facility:

BMHCC System Services

Location:

Memphis, TN
Overview
Summary
The regulatory coordinator is responsible for providing high level administrative support to ensurepliance withplex, 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 understandplex protocols and accuratelyplete 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,pletion 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 areplete and up to date, and participating in study monitoring visits and audits. The coordinator also ensures clinical trial documentation isplete and up to date in multiple spreadsheets, databases and software systems. All of these tasks must bepleted 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 andanizational skills. Knowledge of FDA, GCP and ICH guidelines regarding clinical research.