The Associate Regulatory Attorney role provides a broad range of regulatory support to members of the Regulatory Team and to the organization and its clients in order to establish policy and process infrastructure that supports the mission and goals of the organization.
Advises IRB members, staff, and clients regarding the interpretation of laws, regulations, and guidance related to human subject’s research conducted in the United States, Canada, and other countries.
Responds to inquiries from IRB members, clients, and staff regarding ethical, legal, and regulatory issues including, conflicts of interest, research recruitment practices, HIPAA compliance, accreditation requirements, research ethics, and protection of human subjects, Good Clinical Practice, and local law requirements.
Assists with the review of and changes to Quorum policies, standard operating procedures, procedural work instructions, guidance, forms, IRB guidelines, consent forms, and other documents.
Reviews and revises select IRB directed correspondence.
Develops and delivers training, webinars, and live presentations for Quorum IRB members, staff, and clients.
Position requires occasional travel.
Who You Are:
Juris Doctorate from an accredited law school.
Licensed to practice law in one or more jurisdictions in the United States.
Certified IRB Professional (CIP) or other certifications related to research strongly preferred.
2-5 years of practice in health law, regulatory consulting, and/or related regulatory experience (or an equivalent combination of experience) is required.
Demonstrated working knowledge of regulatory matter related to research oversight, accreditation, and/or compliance is a plus.
Strong interpersonal, negotiation, and communication skills.
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 with customers 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.