Under strategic leadership, this position will develop, maintain and continually improve ongoing educational offerings of IRB, including investigator training, coordinator trainings, and workshops on informed consent, recruitment, eligibility requirements, navigating the submission system, protocol specific trainings, and ad hoc IRB trainings for the research community. Update trainings based on identified needs, QA findings, new regulations, and guidance, etc.
- Provide consultations in the form of direct, one-on-one and small group education on regulatory aspects to the conduct of research throughout the life of the study, including investigator and sponsor responsibilities, study conduct, documentation, consenting, protocol planning, IRB submissions, questions on study implementation, assistance with IRB submissions, consent development and writing, HIPAA issues, planning and submitting protocols to the IRB. Demonstrates familiarity with department operations and makes recommendations for their improvement.
- Manage the Research Seminars training calendar and other similar educational offerings as they are developed.
- Serves as a point of contact for questions related to developing a protocol for submission to the IRB, including questions of IRB support staff, IRB members, researchers and investigators.
- Assists investigators and research staff on IRB submission requirements.
- Conducts education sessions on social, behavioral, and education research studies in compliance with Federal regulations and Institutional policies and procedures. Identifies issues or concerns that must be addressed by investigators in order to secure IRB approval.
- Assists investigators in analyzing, evaluating, and interpreting IRB responses to changes requested by the reviewer and advises investigators on how to make necessary changes to secure approval.
- Identifies potential improvements and enhancements to minimal risk review processes and recommends corresponding changes in procedure. Provides feedback to senior management regarding program efficacy and efficiency.
- Conducts reviews of social, behavioral, and education research studies in compliance with Federal regulations and Institutional policies and procedures. Under supervision, identifies issues or concerns that must be addressed in order to approve the research under the exempt and expedited procedures and records review findings in tracking software in a timely manner.
- Analyzes and evaluates investigators’ responses to changes requested by the reviewer and advises whether the requirements for IRB approval have been met.
- Composes detailed correspondence that effectively describe concerns raised by reviewers, changes required by the reviewer to make the study approvable, and the rationale for the reviewer decisions and requested changes.
- Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.
- Oversight of IRB Education Specialist/Analyst workload.
- Other job-related duties as assigned.
Supervisory Responsibilities: N/A
Education & Experience:
- Master’s degree in related field, required or equivalent combination of education and experience. Terminal degree preferred.
- Minimum of 5 years of IRB related experience and experience with a higher education setting, preferred.
- Certified IRB Professional (CIP) certification is preferred
- Previous experience in reviewing human subjects applications
- Experience developing curriculum relative to IRB research
- Experience teaching adult-learners in a remote environment
- Ability to participate as an active team member of the team and organization and work toward a common goal. Contributes fully to the team effort and plays an integral part in the smooth running of teams without necessarily taking the lead.
- Accepts personal accountability, proactively seeks resolution for personal limitations head-on; and supports honesty and respect towards others, the company and oneself.
- Actively seeks to influence, build effective relationships and gain alignment with peers, functional partners and/or external partners to accomplish business objectives.
- Develops new insights into situations; questions conventional approaches; encourages new ideas and innovations; designs and implements new or cutting-edge programs/processes. Ability to generate and/or recognize imaginative or creative solutions that generate successful outcomes.
- Working knowledge, principles and practices of office management/systems within a higher education environment, preferred. Demonstrates an understanding of underlying organizational issues.
- Ability to drive towards achieving measurable and challenging goals to support organizational success. Demonstrates the ability to focus on achieving results consistent with the organization’s objectives. As a leader, develops goals based on the organization’s vision, mission, strategic goals and objectives.
- Strong interpersonal skills and the ability to effectively communicate with a wide range of individual of constituencies in a diverse community.
- Work independently and foster a cooperative spirit within a large and/or small team of diverse cultures, while working in a fast-paced environment with multiple deadlines and frequently changing priorities.
- Intermediate use of computers and Microsoft Office Suite Applications such as Word, Excel, Power Point, Outlook. Experience using Student Information System (SIS) such as SOAR/Peoplesoft systems.
Travel: Travel required as necessary, may include quarterly college/school meetings, commencement, and conferences.
The National University System is committed to maintaining a high-quality, diverse workforce representative of the populations we serve. As a network of nonprofit educational institutions, the System employs more than 3,300 faculty and staff and serves over 41,000 students. We are united in our mission to meet the global education demands of the 21st Century and are dedicated to creating a supportive academic and work environment that allows for students, faculty and staff to develop their interests and talents while experiencing a sense of community and a commitment to diversity. With programs available both online and at our many campus locations, the National University System is a leader in creating innovative solutions to education and meeting the needs of our diverse student population, including adult learners and working professionals.
National University offers an opportunity to work in an innovative environment that supports diversity.
National University (NU) is proud to be an equal opportunity employer and does not unlawfully discriminate against any employee or applicant for employee per applicable federal, state and local laws. At NU, a diverse mix of highly talented, innovative and creative people come together to make the impact of a lifetime for each of our student learners. All qualified applicants will receive equal consideration for employment, education, and admission at National University. We are focused on equality and believe deeply in diversity of race, color, ancestry, age, family care status, veteran status, marital status, creed, religion, sex, gender, sexual orientation, religion, ethnicity, national origin, and other legally protected group status.
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