Quorum Review is hiring for a IRB Regulatory Counsel!
The IRB Regulatory Counsel is responsible for providing regulatory counsel to the IRB, IBC and organization in order to ensure compliance and establish policy and process infrastructure that supports the mission and goals of the organization.
Develop and maintain an efficient and accurate regulatory support program for the IRB and IBC that is standardized and repeatable
Monitor changes in applicable laws, regulations, guidance, and accreditation standards related to research.
Advise staff and IRB members regarding the interpretation of laws, regulations, and ethical issues related to human subjects research and life sciences product development conducted in the United States, Canada, and other countries
Respond to questions from the Board, staff, and clients regarding regulatory issues pertaining to human subjects research
Review outgoing correspondence as necessary (e.g., Board directed correspondence and agency correspondence)
Recommend revisions to guidelines, standard operating procedures, consent forms, participant material, and other documents in accordance with applicable laws, regulations, guidance, and accreditation standards
Assist with internal audits, client audits, agency inspections, and other compliance functions when necessary
Interact with sponsors, CROs, sites, institutions, agencies, and other organizations on behalf of the company
Collaborate cross-departmentally on operational initiatives
Provide content for marketing materials such as white papers, webinars, blogs, and presentations
Represent the IRB at industry conferences or work groups as necessary
Performs other duties as assigned
Position requires occasional travel
Who You Are:
Licensed attorney with a Juris Doctorate from an accredited law school
Member of the Washington State Bar or eligible to be House Counsel in Washington
CIP - Certified IRB Professional
CHRC - Certified Healthcare Research Compliance
CCEP - Certified & Compliance Ethics Professional
2 – 4 years of experience in research law and related FDA and HHS regulatory experience
Prior IRB experience
Demonstrated working knowledge of regulatory matters related to research oversight
Who We Are:
Our workplace environment offers an informal office environment, open door policy, and strong mentorship from existing staff and management. Our office is in downtown Seattle close to shopping, restaurants and Pike Place Market and our customers are across North America.
We offer competitive pay for this position along with an excellent benefits package. We have employer-paid medical, dental, vision coverage; and subsidized health insurance for families and domestic partners. We offer a competitive PTO plan, plus 8 paid and 4 floating holidays. Our retirement savings 401(k) plan is matching up to 4% and we provide commuter transit benefits with an Orca card or parking subsidy. Additional benefits include the Flexible Spending Account, Life Insurance, Short Term and Long Term Disability and an Employee Assistance Program.
Quorum Review is one of the largest Independent Review Boards in the US. Our review ensures the safety and well-being of people participating in clinical trials. We are passionate about the services we provide and proud of the customer focus that has grown our business. We are a progressive and growing company in Seattle and have developed an excellent reputation for quality and service. As an industry leader, Quorum is preferred by research organizations for our friendly, prompt customer service, high standards, and quality documentation.
Quorum Review IRB is the first name in streamlined, service-centered independent ethics and regulatory review. The Quorum difference is One-Touch Collaboration™. Your research benefits from an outstanding service experience, a single point of contact, one study startup timeline, and a true single board review—which is why Quorum is the preferred central IRB. Beyond traditional institutional review board services, Quorum offerings include single IRB (sIRB) services for institutions and the world’s first IRB-integrated electronic informed consent solution: Q Consent™. Kinetiq, the consulting and technology division of Quorum, provides services that enhance and optimize the clinical research process.