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The Emmes Company, LLC is searching for an IRB Coordinator located in our Rockville, Maryland or Frederick, Maryland office. Emmes provides flexibility for office location preference, dependent upon position.
The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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 provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
In support of the NIH’s Precision Medicine Initiative, Emmes provides logistical and operational support in addition to ongoing monitoring and review of scientific, ethical, and regulatory compliance in human subject research projects for NIH’s All of Us (AoU) Research Program. The IRB Coordinator will support the established AoU IRB.
Assist in development of new and revision of existing policies and procedures in support of the AoU IRB
Working with the IRB Chair(s) and members to ensure that all research and related items submitted to the IRB(s) are reviewed and acted upon in a timely manner in accordance with AoU IRB SOPs
Ensure progress of the review of all study submissions through the approval process
Manage communications between the IRB, Study Chairs, Research Program Representatives, and the IRB Operations Office
Serve as a resource to the human subjects protection program to questions on preparing submissions and compliance with SOPs
File regulatory documents appropriately to maintain accurate and complete records of all IRB activities, including drafting of IRB agenda and meeting minutes
Maintain databases for tracking studies and IRB submissions
Assist in the development of tools and educational resources to support the AoU IRB’s review of research
Review all submissions for completion and identify regulatory concerns prior to review by the AoU IRB
Coordinate expedited review of eligible submissions
Communicate IRB determinations to relevant parties
Attend AoU IRB meetings
Develop and present continuing education resources for AoU IRB members
Assist with additional tasks as needed
Bachelor’s Degree and related experience in health-related field
Minimum 2 years’ IRB experience
Independent decision making and the ability to make good judgements 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 protocol 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
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs
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The Emmes Company, LLC 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.
Internal Number: 2141
About The Emmes Company, LLC
The Emmes Company, LLC, 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.