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.
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.
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
College degree preferred
At least one year of IRB experience required
Independent decision making and the ability to make good judgement are critical
Knowledge of the federal laws and regulations governing the conduct of research with human subjects is essential (21 and 45 CFR)
Exceptional oral and written communication skills when interacting with the client and investigators submitting protocols to the IRB
Ability to learn and use complex computer systems/databases
Attention to detail and accuracy in reporting the actions of the IRB are essential
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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
Telecommuting is allowed.
Internal Number: 1981
About The Emmes Corporation
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.