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