The Emmes Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO).  Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India.  Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. 

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents.  We offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. 

Primary Purpose

Emmes is seeking an Institutional Review Board (IRB) Coordinator to support the expanding activities of the National Cancer Institute Central Institutional Review Board (NCI CIRB).  The IRB Coordinator will support the established NCI CIRB.  This position can work from either our Rockville, MD or Frederick, MD office.

Primary Responsibilities:

• Working with the IRB Chair and members to ensure that all research and related items submitted to the IRB are reviewed and acted upon in a timely manner in accordance with IRB SOPs
• Review submitted protocols and ensure compliance with federal regulations
• Manage communications between the IRB, sponsors, PIs, and the IRB office
• Recommends primary and secondary reviewers for protocol review
• Draft and distribute IRB meeting agendas and protocol documents for review
• Draft and distribute IRB minutes in a timely manner per IRB SOPs
• Document the IRB’s determinations in letters and distribute to stakeholders
• File regulatory documents appropriately to maintain accurate and complete records of all IRB activities
• Maintain databases for tracking studies and IRB submissions
• Maintain current references on regulations and policies
• Serve as a resource to the human subjects protection program to questions on preparing submissions and compliance with SOPs
• Assist in development of new and revision of existing SOPs
• Assist in the development of tools and educational resources to support the IRB’s review of research and training of IRB members
• Coordinate expedited review of eligible submissions
• Assist with additional tasks as needed