Central IRB Coordinator

Overview

Central IRB Coordinator

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

In support of the National Cancer Institute’s Central Institutional Review Board (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 IRB 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
  
  

Qualifications

• Minimum 2 years’ IRB experience. Oncology clinical trial environment preferred.
• 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.
  
  

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:

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment
  
  

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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.