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CIRB Coordinator

Company: The Emmes Company, LLC
Location: Rockville
Posted on: January 25, 2023

Job Description:

CIRB Coordinator
US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose
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. The CIRB Coordinator will support the established NCI CIRB.

Responsibilities



  • Provide regulatory, administrative and logistical support before, during and after convened IRB meetings



  • Assist in development of new and revision of existing policies and procedures in support of the CIRB



  • Maintain and update the regulatory file database and electronic IRB submission system



  • Review all submissions for completion and identify regulatory concerns prior to review by the CIRB



  • Work with the IRB Chair(s) and members to ensure that all submissions to the IRB(s) are reviewed and acted upon in a timely manner in accordance with CIRB SOPs



  • Monitor and ensure the progress of study submissions through the approval pathway



  • Manage communications between the IRB, NCI, Study Chairs, and CIRB Operations Office



  • Serve as a resource to the research community and NCI human research protection program, particularly with regards to questions on preparing submissions and compliance with CIRB SOPs



  • File regulatory documents appropriately to maintain accurate and complete records of all IRB activities



  • Assist in the development of tools and educational resources to support the CIRB's review of research



  • Coordinate expedited review of eligible submissions



  • Communicate CIRB determinations to relevant parties



  • Assist in answering Helpdesk queries related to CIRB activity as needed



  • Assist with additional tasks as needed



    Experience


    • Bachelor's Degree preferred with related experience in health-related field; oncology clinical trial environment preferred



    • 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





      Why work at Emmes?
      At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:






      • Unlimited Approved Leave







        • Tuition Reimbursement







          • 401k & Profit Sharing Plan






            • Work From Home Anywhere in the US







              • Maternal/Paternal Leave







                • Casual Dress Code & Work Environment






                  CONNECT WITH US!
                  Follow us on Twitter - @EmmesCRO
                  Find us on LinkedIn - The Emmes Company, LLC

                  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.
                  Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Keywords: The Emmes Company, LLC, Rockville , CIRB Coordinator, Other , Rockville, Maryland

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