Institutional Review Board (IRB) Coordinator

Save
You need to sign in or
create an account to save a job.
IRB 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 NIH's Precision Medicine Initiative, Emmes provides logistical and operational 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 (AoU) Research Program. The IRB Coordinator will support the established AoU IRB.

Responsibilities
  • Assist in development of new and revision of existing policies and procedures in support of the AoU IRB
  • 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 AoU IRB SOPs
  • Ensure progress of the review of all study submissions through the approval process
  • Manage communications between the IRB, Study Chairs, Research Program Representatives, and the IRB 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 AoU IRB's review of research
  • Review all submissions for completion and identify regulatory concerns prior to review by the AoU IRB
  • Coordinate expedited review of eligible submissions
  • Communicate IRB determinations to relevant parties
  • Attend AoU IRB meetings
  • Develop and present continuing education resources for AoU IRB members
  • Assist with additional tasks as needed

Experience
  • Bachelor's Degree and related experience in health-related field
  • 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


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.

Similar searches: Full Time, Experienced (Non-Manager), Science