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Assistant Director, Harvard University Area IRB

Assistant Director, Harvard University Area IRB

locationUnited States
PublishedPublished: 3/31/2024
Full Time

29-Mar-2024

Assistant Director, Harvard University Area IRB

University Administration

65461BR

Job Summary

Under the direction of (and reporting directly to) the Director of the Human Research Protection Program (HRPP), the incumbent is responsible for providing leadership and oversight for review operations of the Harvard University Area (HUA) IRB, including the management and supervision of IRB review staff.  The incumbent is required to work independently with minimal supervision in selecting and applying established regulations and procedures appropriately.

The Assistant Director provides outreach to the HUA research community and assists in and has oversight of IRB initiatives as directed. They support the IRB staff, IRB Chairperson, and other IRB members by providing professional analytical and technical assistance while interacting closely with researchers from University-area schools including the Faculty of Arts and Sciences, Harvard Kennedy School of Government, Harvard Graduate School of Education, the Harvard Law School, Harvard Divinity School, Harvard Graduate School of Design, Harvard University Health Services, Radcliffe Institute for Advanced Study, Harvard School of Engineering and Applied Sciences, and Harvard Business School.
 

Position Description

Supervise IRB Administrators:

  • 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.
Manage Convened IRB Workflow:
  • 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.
IRB Initiatives and Office Management: Lead or participate in HUA HRPP-related initiatives and activities, including QA/QI, educational, and compliance activities, as well as activities of regular IRB office operations. Activities may include: 
  • 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.
Manage Review Portfolio & Regulatory Responsibilities: The Assistant Director may be responsible for carrying a moderate portfolio of IRB reviews. The Assistant Director independently approves human subjects research in their capacity as an Alternate Member of the HUA IRB and is identified by the IRB Chair as an experienced IRB reviewer who conducts activities on behalf of the IRB. In this capacity they:
  • 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.

Basic Qualifications

Candidates MUST meet the following basic qualifications to be considered for this role:

  • 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.

Additional Qualifications and Skills

Demonstrated knowledge and understanding of the federal regulations on human research protections. Demonstrated proficiency in the MS Office Suite of computer applications. Strong written and oral communication skills are essential, with demonstrated ability to organize, write about and discuss regulatory and complex issues clearly. The ability to communicate with highly diverse group of people with sensitivity to cultural differences. Proven ability to take initiative and work both independently and as a team member; ability to manage multiple projects simultaneously and work well under deadlines. Familiarity with electronic database and automation systems strongly preferred. An advanced degree in social or behavioral science, law, or public health is preferred. Experience working in a fast-paced academic research environment and with faculty from various academic disciplines is preferred. Certification of Collaborative Institutional Training Initiative (CITI) training on human research protections will be necessary.

Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development.

Understand IRB requirements, federal and state regulations, state law, University policies, and the ethical principles that apply to human research projects and apply them to study reviews and communication with researchers; Act as a resource to IRB review staff.
 

Additional Information

The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up to date on CDC-recommended vaccines. 

Work Format Details

This is a hybrid position that is based in Massachusetts. Additional details will be discussed during the interview process. All remote work must be performed within one of the Harvard Registered Payroll States, which currently includes Massachusetts, Connecticut, Maine, New Hampshire, Rhode Island, Vermont, Georgia, Illinois, Maryland, New Jersey, New York, Virginia, Washington, and California (CA for exempt positions only). Certain visa types and funding sources may limit work location. Individuals must meet work location sponsorship requirements prior to employment.

Benefits

We invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards) to learn more about our outstanding benefits package, which may include:

  • 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.

Job Function

General Administration

Department Office Location

USA - MA - Cambridge

Job Code

359057 Admin Dept/Program Admin

Work Format

Hybrid (partially on-site, partially remote)

Sub-Unit

Office of the President and Provost

Salary Grade

057

Department

IRB

Union

00 - Non Union, Exempt or Temporary

Time Status

Full-time

Pre-Employment Screening

Education, Identity

Schedule

Full time. Monday through Friday. 35 hours per week. 

Commitment to Equity, Diversity, Inclusion, and Belonging

Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.

EEO Statement

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.

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