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IRB Coordinator

Overview:
IRB Coordinator

US Remote

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 All of Us (AoU) IRB, 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 NIH’s All of Us Research Program. The IRB Coordinator will support the established AoU IRB.
Responsibilities:
  • Provide administrative and logistical support before, during and after convened IRB meetings
  • Process expedited continuing and amendment reviews
  • Contribute to the monthly progress report
  • Draft and distribute letters to institutions
  • Distribute continuing review reminder notices
  • Schedule IRB review of studies
  • Maintain a record of all documents reviewed by the AoU IRB
  • Upload files and data into regulatory file database, as needed and requested
  • Maintain and update the regulatory file database and electronic IRB submission system
  • Assist with additional tasks as needed
Qualifications:
  • Minimum 2 years’ IRB experience
  • Bachelor’s degree and CIP credential preferred
  • Knowledge of the federal laws and regulations governing the conduct of research with human subjects (21 CFR 50 and 45 CFR 46)
  • Excellent oral and written communication skills and the ability to interact professionally with others one-on-one and as part of a team
  • Ability to set priorities and maintain a high level of organization while managing large volumes of information and multiple deadlines
  • Must possess a high degree of initiative and the ability to work independently
  • Ability to learn and use complex computer systems/databases
  • Attention to detail and accuracy in reporting the actions of the IRB are essential

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing.
Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

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 Retirement 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.
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CEO of The Emmes Company
The Emmes Company CEO photo
Anne S. Lindblad
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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...

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DATE POSTED
August 4, 2023

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