Senior CIRB Coordinator

Senior 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 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 Senior IRB Coordinator will support the established NCI CIRB.

Primary Responsibilities

· Act as a key team member of the NCI CIRB Operations Office.

· Provide support for coordinators of all four boards that comprise the CIRB, performing all the duties of a coordinator for the CIRB.

· Provide leadership and regulatory and logistical support for the four boards that comprise the CIRB.

· Develop new and revise existing policies and procedures in support of the CIRB

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

· 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

· Review consent forms to ensure they adhere to the NCI consent template

· 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

· Develop tools and educational resources to support the CIRB's review of research

· Communicate CIRB determinations to relevant parties

· Assist with additional tasks as needed



Experience

· Bachelor's Degree and related experience in human subjects research and/or IRB administration required

· CIP credential and oncology clinical trial environment preferred

· Knowledge of the federal laws and regulations governing the conduct of research with human subjects is essential (21 CFR 50 and 56 and 45 CFR 46)

· Must possess a high degree of initiative and the ability to work independently

· Ability to set priorities and maintain a high level of organization while managing large volumes of information and multiple deadlines

· Excellent oral and written communication skills and the ability to interact professionally with others one-on-one and as part of a team

· Attention to detail, problem solving, and the ability to make good judgements are critical

· Ability to learn and use complex computer systems/databases

Emmes only requires all US new hires in the following job categories to be fully vaccinated before their first day of employment: (i) Clinical Research Associates (CRAs), (ii) Associate CRAs, and (iii) all CRA line managers. 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



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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.