Institutional Review Board and Human Research Protection Program Senior Analyst

Academics United States San Diego, California


Description

 

Position Summary:

The Institutional Review Board (IRB) and HRPP (Human Research Protection Program) Senior Analyst serves as a regulatory Subject Matter Expert (SME) exercising independent judgment to advise faculty, staff, students and ancillary committees on Institutional Review Board (IRB) regulations, policies, and practices. This role leverages expertise as a secondary point of contact for questions, for decision-making and problem-solving for day-to-day IRB operations and to conduct reviews of social, behavioral, and education research studies in compliance with federal regulations and institutional policies and procedures.

 

Essential Functions:

  • Serves as a regulatory SME exercising independent judgment in advising faculty, staff, students and ancillary committees on Institutional Review Board (IRB) regulations, policies, and practices.
  • Demonstrates expertise as a secondary point of contact for questions, and for decision-making and problem-solving for day-to-day IRB operations including the independent analysis needed for resolution of technical problems in the submission system and questions from IRB support staff, IRB members, researchers and investigators.
  • Conducts independent reviews of social, behavioral, and education research studies in compliance with federal regulations and institutional policies and procedures. In collaboration with leadership, identifies issues or concerns to 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.
  • Assists investigators and research staff on IRB submission requirements.
  • Serves as a member of the Institutional Review Board (IRB) and designated reviewer with the authority to make determinations with minimal supervision, to approve expedited research, and to approve changes in approved research that are eligible for expedited review.
  • Attends Institutional Review Board (IRB) meetings to provide technical support, guidance on regulatory matters and ethics, and provide critical analysis of proposal content. Provides answers to questions raised by the board members.
  • Conducts reviews of social, behavioral, and education research proposals submitted to the IRB in compliance with federal regulations and institutional policies and procedures. Makes an initial determination regarding the necessary level of review. Identifies issues or concerns that must be addressed in order to approve the research.
  • Composes detailed and complex meeting minutes and correspondence that effectively describe concerns raised by board reviewers, changes required by the board to make the study approvable, and the rationale for the board’s decisions and requested changes.
  • Strong support in the training of and mentoring of Institutional Review Board Analysts and other staff as needed.
  • Collaborates in the development of IRB education, training, and guidance materials for the research community.
  • Demonstrates familiarity with department operations and makes recommendations for their improvement.
  • Other job-related duties as assigned.

 

Requirements:

Education & Experience:

  • Masters degree in related field or 3 years relevant experience; or equivalent combination of education and experience.
  • Certified Institutional Review Board Professional eligibility required.
  • Preferred:
    • Certified IRB Professional (CIP) certification is preferred
    • Previous experience in reviewing human subjects applications
    • Knowledge of 45 CFR 46 and all subparts

 

Competencies/Technical/Functional Skills:

  • Subject matter expertise required to be a member of an IRB board and conduct expedited review.
  • Knowledge of federal, state, local regulations and laws, and routine policies and ethical practices for human subjects research.
  • 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.
  • Intermediate use of computers and Microsoft Office Suite Applications such as Word, Excel, Power Point, Outlook.
  • 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. Excellent written and oral communication skills.
  • 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.

 

Location: Remote

 

Travel: No Travel Required

 

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.

The National University System offers a comprehensive benefits package, competitive salaries, and an opportunity to work in an innovative environment that supports diversity. It is our policy to provide equal employment opportunities for all applicants and employees. The System does not unlawfully discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), national origin, ancestry, age, physical disability, mental disability, medical condition, family care status, veteran status, marital status, sexual orientation or any other basis protected by state of federal laws.