Assistant Director of Research Compliance, Quality Improvement Program
10-May-2024
Assistant Director of Research Compliance, Quality Improvement Program
Harvard Business School
65858BR
Job Summary
The Assistant Director is a member of a cross-functional team supporting a wide range of research programs and activities for the Harvard Business School (HBS) faculty and its governance. In partnership with the Director of Research Compliance, the Assistant Director has primary responsibility for developing and implementing the Quality Improvement Program (QIP) at HBS, a Program that will provide a variety of human research and regulated data support and education to the HBS research community, and will work closely with the Compliance Team to advise investigators throughout the IRB process.
Additionally, as part of the Research Compliance team, the Assistant Director will provide services and training to the HBS research community, and work to ensure compliance with federal, state and local research regulations, as well as HBS and Harvard University policies and procedures related to regulated research. The Assistant Director will also partner with HBS research community stakeholders and the Assistant Director of Research Compliance, Data Management, to help establish a coherent and comprehensive set of processes, procedures, and guidance around proper research data management practices.
Position Description
Reporting to the Director of Research Compliance, and working closely with the Assistant Director of Research Administration and Human Subjects Protection, and other members of the Research Compliance and Research Administration teams, the Assistant Director will focus on supporting the research and scholarly activities of the HBS faculty by building and operationalizing a comprehensive Quality Improvement Program and associated guidance and training. S/he will assist faculty and staff with research study support requests, IRB submission assistance and review, study start-up and close-out consultation, and ensure the ethical principles that apply to research projects are reflected in study documentation and adhered to. The Assistant Director will also support the Research Compliance team’s operations and support special projects as needed.
The Assistant Director’s principal duties and responsibilities include:
Quality Improvement Program (QIP) oversight:
- Creating and implementing short- and long-term objectives for QIP, including but not limited to documenting intake parameters and processes, standardizing expectations for required reviews, trainings and approvals, and strategizing engagement with other HBS and University stakeholders who are involved in research procedures.
- Developing and delivering educational curriculum specific to the HBS research community by request and when initiated by the HBS Research Compliance team, including providing guidance to researchers and administrators on processes and requirements related to human subjects research and the research lifecycle.
- Providing front-line support and information for researchers and staff, including HBS faculty, students, staff, and other research team members. This may include consulting on effective study design, recommendations for best practices for the maintenance of study sites, and on-site monitoring to ensure appropriate implementation.
- Working closely with the Assistant Director of Research Administration and Human Subjects Protection, as well as with Harvard University’s Committee on the Use of Human Subjects (CUHS) and Longwood Medical Area QIP to ensure policies and procedures are consistently applied at HBS.
- Drafting reports (including analysis of compliance records), study management tools, and other QIP materials.
- Developing a strategy for the dissemination of QIP materials, including the Research Compliance newsletter and associated web content
- Supporting Compliance team processes and procedures to help aid regulatory compliance, including protocol adherence, accurate record keeping, onboarding, and use of appropriate tools and resources.
- Contributing to the QIP’s goals by accomplishing other related duties as required, and as may be assigned by the Director of Research Compliance, such as study team outreach activities, supporting responses to instances of non-compliance, data analysis, etc.
- Reviewing IRB submissions by HBS faculty to ensure completeness and compliance with applicable federal regulations, state laws, Institutional requirements, and IRB policies. This includes:
- Identifying protocols that do not meet the regulatory criteria for human subject research,
- Determining whether research projects are exempt from further review;
- Reviewing and approving certain research projects as a designated reviewer;
- Corresponding with researchers, articulating required modifications to study documentation, including consent forms, in order to secure approval, and requesting additional information needed before approval can be considered.
Basic Qualifications
- Bachelor’s degree or equivalent work experience required
- Minimum of 7 years’ relevant work experience
Additional Qualifications and Skills
Other Required Qualifications:
- Applicants with a Master’s degree and 5 or more years of experience will be considered. Applicants with a PhD or JD and at least 3 years of experience will also be considered.
- Experience with human subject protection and related regulations normally acquired through employment with an IRB preferred.
Additional/Desired Qualifications:
- Experience using research compliance/research administration software (e.g. Huron Compliance Suite), or a similar IRB electronic-system software in the review of social / behavioral research protocols.
- Experience using project management software to manage and track special projects and organize the Research Compliance operations.
- Experience guiding researchers on best practices for managing data and ensuring data are compliant with IRB submissions, data security requirements, and research agreements preferred.
- Experience in successfully managing projects from inception through completion (i.e., pre-review and designated review).
- Excellent judgment and sound decision-making skills.
- An understanding of and ability to manage highly confidential information.
- The ability to communicate with a diverse group of people with sensitivity.
- Demonstrated ability to work effectively in a complex organization and across multiple units and levels.
- Ability to take initiative and work independently with an entrepreneurial spirit, flexibility, and high-capacity assess priorities and to meet competing deadlines.
A strong customer service orientation, and excellent interpersonal
Additional Job description:
Research Compliance Program Support
- Developing guidance and education materials for researchers and research support staff on appropriate data management activities throughout the research life cycle, including advising on the importance of utilizing secure tools and resources, project start-up and closeout, and organizing data to prepare for future publications and deposition.
- Working with Research Compliance team members to document and refine workflows, guidance, and communications related to research collaborations involving access to regulated and confidential data and results.
- Guiding researchers on use of the Huron Research Compliance Suite system (e.g., IRB, Data Security, Data Use Agreement), the internal system required to manage applications for research reviews, approvals and correspondence.
Additional duties and responsibilities include, but are not limited to, the following:
- Maintaining active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to research activities through continuous professional development.
- Providing coverage to other Research Compliance team members based on research landscape and need.
- Other duties as assigned.
Additional Information
This role is offered as a hybrid (some combination of onsite and remote) where you are required to be onsite at our Boston, MA-based campus 3 days per week. Specific days and schedules will be determined between you and your manager.
We may conduct candidate interviews virtually (phone and/or via Zoom) and/or in-person for this role.
A cover letter is required to be considered for this opportunity.
Harvard Business School will not offer visa sponsorship for this opportunity.
Culture of Inclusion: The work and well-being of HBS is profoundly strengthened by the diversity of our network and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. Explore more about HBS work culture here https://www.hbs.edu/employment.
About Us
Founded in 1908 as part of Harvard University, Harvard Business School (www.hbs.edu) is located on a 40-acre campus in Boston. The School offers two full-time MBA and PhD programs, more than 175 Executive Education programs, and certificates and courses through Harvard Business School Online. For more than a century, Harvard Business School faculty have drawn on their research, connection to practice, global expertise, and passion for teaching to educate leaders who make a difference in the world. The School and its curriculum attract the boldest thinkers and the most collaborative learners who will shape the practice of business and entrepreneurship around the globe.
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
Faculty & Student Services, General Administration, Research
Department Office Location
USA - MA - Boston
Job Code
358057 Admin Pro/Indiv Contrib
Work Format
Hybrid (partially on-site, partially remote)
Sub-Unit
------------
Salary Grade
057
Department
Division of Research and Faculty Development
Annual Salary Range
$95,000 - $105,000
Union
00 - Non Union, Exempt or Temporary
Time Status
Full-time
Pre-Employment Screening
Criminal, Education, Identity
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.