RTI International is one of the world’s leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our more than 4,200 professionals provide research and technical services to governments and businesses over 40 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy, and the environment.
RTI International seeks a Senior Human Research Professional to join the Office of Research Protection as an IRB Senior Regulatory Affairs Professional/Senior IRB Manager with opportunity for a career path leading to an Associate Director position with requisite experience and superior performance. The Office of Research Protection is responsible for ensuring compliance with all regulations related to the protection of human research subjects. This includes maintaining RTI's Federal wide Assurance (FWA) with OHRP, operating two IRB committees, conducting not human research and not engaged determinations, exemption determinations and expedited reviews, assisting RTI researchers in developing appropriate procedures for their studies, coordinating reliance agreements, providing post-approval IRB oversight, and conducting training with IRB members and researchers. The Office strives to maintain a collaborative relationship with researchers with the shared goal of conducting ethical human research.
Reporting to the Director of the Office of Research Protection, and working collaboratively with the Senior ORP Legal and Regulatory Manager, the Senior IRB Manager would be responsible for:
Leading and supporting efforts to improve compliance with human subjects protection policies and procedures, with a focus on continuous improvement and ensuring ethical conduct of research.
Conducting not human research, not engaged and exempt determinations and expedited reviews of protocols.
Consulting with researchers to discuss strategies for addressing challenging, novel, or complex human subjects protection issues.
Managing the day-to-day operations of the Office and IRB Committees.
Serving as a Chair of one of RTI’s IRB Committees.
Designing and planning special projects to enhance office procedures, IRB performance, or overall human subjects protections.
Providing support to the Director and Senior ORP Legal and Regulatory Manager and serving in their stead in their absence.
Overseeing and occasionally conducting administrative tasks such as study audits.
Assisting the ORP Legal Manager in updating and maintaining the IRB SOPs to ensure accurate information and compliance with applicable regulations and guidance and suggesting changes to the IRB Director.
Assisting the Director and ORP Legal Manager with the ongoing implementation and upgrade to the electronic submission system (IRB Express – a Huron product) to improve operational efficiencies in IRB reviews.
Assisting the Director with supervision of IRB Coordinators and the IRB Administrative Assistant including providing oversight of pre-reviews and vetting of calls to the IRB toll free number from human subjects.
Participating in the development and delivery of human subjects outreach and training programs.
Utilizing the online IRB submission system (IRB Express) to provide monthly support on relevant metrics for the Office of Research Protection and reviewing these reports with the ORP Director; and
Assessing the level of effort and developing a plan for initiating the AAHRPP accreditation process within the next 5-10 years and preparing related documents.
Bachelor's Degree and 15 years of experience, Master's degree and 12 years of experience, PhD and 8 years of experience, or equivalent combination of education and experience.
MA/MS/MPH/JD/PhD in a research, legal, scientific or related technical field is highly preferred.
Certified IRB Professional (CIP) is desirable. Other evidence of regulatory expertise is acceptable.
At least 8 years of experience in IRB administration and/or human subjects research oversight is required (in combination with education requirements). Prior experience as an IRB Chair or IRB staff member for an academic, government, or commercial organization.
Extensive knowledge of DHHS/FDA federal human subjects regulations (The Common Rule, 45 CFR 46, 21 CFR 50 and 56, and agency specific revisions/additions to the Common Rule), related guidance, and appreciation of related regulatory, ethical and compliance principles.
Familiarity with other regulations and guidance (e.g., HIPAA, GDPR) that may be applicable in some studies conducted by RTI researchers.
Expertise in conducting or overseeing behavioral sciences and/or clinical trials and/or, investigator-initiated studies, contract and grant-supported research or related areas. Demonstrated expertise and ability to comprehend the research process and the various components. Thorough knowledge and experience with quantitative and qualitative research design.
Experience conducting exempt and/or not research determinations and/or expedited reviews.
Experience as an IRB member, Experience as an IRB Chair is highly preferred.
This position requires excellent organizational skills and strict attention to detail. In addition, strong oral and written communication and interpersonal skills will be necessary to interact with multiple individuals and entities across a large organization. The candidate must have demonstrated independent analytical and problem-solving abilities.
Knowledge or experience with IRB accreditation standards and processes is preferred; Membership in national or regional human subjects organization is preferred.
Telecommuting is allowed.
Internal Number: 210XS
About RTI International
RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.