Advisory / Regulatory, Medical Review Organization, Office of Physicians
As an IRB Member, this role provides professional medical expertise in the review of protocols and other study materials as submitted for convened Board or Expedited Review. As an Expedited Reviewer, this role provides independent medical judgment in the review of submitted requests for the initial review or changes in research in accordance with established regulations, policy, and guidelines. As a Medical Reviewer, this role reviews and assesses safety information.
IRB Member Duties
Attend Board meetings and make recommendations to the Board on regulatory issues, provide rationale, and justification for recommendations.
Provide necessary background information to the Board to assist their review.
Evaluate and present new protocols, protocol amendments, and other items to the Board, based on expertise.
Interpret and apply Federal Regulations, and Quorum’s HRPPP guidelines in a manner that assures Quorum’s full compliance with all applicable regulations and guidelines.
Expedited Review Duties
Determine whether requests for initial review of research or changes in research meet regulatory guidance in order to be considered appropriate and suitable for Expedited Review (EXR). Conducts appropriate research as necessary to make this determination.
Has authority to approve review requests, as submitted through the Expedited Review (EXR) process using regulatory guidance and knowledge of the preferred Board approach and Board policy.
Determine when changes in research are not appropriate for expedited review and refer these to a convened Board for review.
Who You Are:
3-5 years of experience in a medical practice, clinical or biotechnology, or pharmaceutical setting
Medical degree from an accredited medical school
Experience with Title 21 Code of Federal Regulations
Strong time management and critical thinking skills
Effective interpersonal and negotiation 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.