EMMES is seeking an Institutional Review Board (IRB)Coordinator to support the expanding activities of the National Cancer Institute’s Central IRB (CIRB), which currently supports four IRBs. The IRB Coordinator will support the establishment of a new CIRB for review of cancer prevention and control trials.
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
Bachelor’s Degree and related experience in health-related field; oncology clinical trial environment preferred
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
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.
*For immediate consideration please submit your resume and apply directly through the company website at www.emmes.com .
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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.
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.