The Emmes Company, LLC is searching for an IRB Coordinator
based out of our Rockville, Maryland, Frederick, Maryland or Tysons Corner, Virginia office. Emmes provides flexibility for the office location or work remote preference dependent upon position.
The Emmes Company, LLC is a 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 are dedicated to providing 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. Primary Purpose
The IRB Coordinator is responsible for supporting the established NCI CIRB. In support of the NCI CIRB, Emmes provides logistical and IT support in addition to ongoing monitoring and review of scientific, ethical, and regulatory compliance in human subject research projects for NCI's Clinical Trials Programs. Responsibilities
- Assist in development of new and revision of existing policies and procedures in support of the CIRB
- 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 CIRB SOPs
- Ensure progress of the review of all study submissions through the approval process
- Manage communications between the CIRB, NCI, Study Chairs, and CIRB 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 CIRB's review of research
- Review all submissions for completion and identify regulatory concerns prior to review by the CIRB
- Coordinate expedited review of eligible submissions
- Communicate CIRB determinations to relevant parties
- Attend CIRB meetings
- Assist in answering Helpdesk queries related to CIRB activity as needed
- Assist with additional tasks as needed
CONNECT WITH US!!
- Bachelor's Degree and related experience in health-related field; oncology clinical trial environment preferred
- Certified IRB Professional (CIP) preferred
- Minimum 5 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
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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.