Assistant Director, Harvard University Area IRB
Harvard University
- Cambridge, MA
- Permanent
- Full-time
- Bachelor's degree with a minimum of 5 years of experience relevant to the field of human subjects research protections.
- Previous supervisory experience is required.
- Hire and supervise IRB review staff, including but not limited to: monitoring workload, providing training opportunities, reviewing work, as well as mentoring and performance management in order to ensure quality standards are met.
- Oversee workload and flow; supervise pre/post meeting activities; provide regulatory expertise and guidance for faculty chair and members; prepare meeting agenda and minutes; ensure the IRB determinations/decisions are communicated to investigators in a timely manner;
- Develop and execute annual IRB member evaluation and facilitate ongoing IRB member training, as needed.
- Developing and maintaining HUA HRPP toolkit materials related to IRB review, including policies and procedures, SOPs, checklists/worksheets, forms/templates, and guidance manuals;
- Developing and implementing institutional policies and procedures that support the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation. Preparing reports and other materials in support of ongoing accreditation;
- Representing the HUA IRB within the Harvard community, including in the IRB submission system (ESTR) governance structure and HUA IRB Advisory Committee;
- Managing the Undergraduate Research Training Program (URTP) including oversight of the program (i.e., monitoring incoming submissions, managing distribution, and troubleshooting issues); managing URTP Advisory Committee (i.e., leading quarterly meetings, developing agenda, writing meeting minutes, ensuring action items are completed); and continued development and growth of the program;
- Developing and implementing training initiatives for IRB staff, IRB members, HUA researchers, and participant outreach including the coordination of continuing education and development of professional development opportunities;
- With the Director, managing daily operations of the IRB office including addressing participant concerns, external requests to study the Harvard community, other inquiries, and other duties as required.
- With the Director and QA/QI staff, performing regular and annual reviews of IRB operations benchmarks, including workload volume, turnaround time, etc., and participating in ongoing QA/QI projects.
- Correspond and meet with researchers, providing guidance on research development, the applicability of human subjects regulations and/or other laws and policies; strategize with researchers on how to conduct research in a manner that is both compliant with regulatory demands and meets research project expectations
- Conduct scientific and scholarly review of research design as required;
- Analyze and review research protocols to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and Harvard University-Area IRB guidelines;
- Determine whether research projects are exempt from further review;
- Review and approve non-exempt research projects as an Alternate Member of the HUA IRB;
- Correspond with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered;
- Investigate and resolve issues of noncompliance.
- Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers.
- Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date.
- Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
- Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service.
- Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.
- Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions.
- Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.
- Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more.
- Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.