Assistant Director of Research Compliance, Quality Improvement Program

Description

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.

IRB Support

• 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:

·         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.

·         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

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

To apply online, visit: https://jobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?PageType=JobDetails&partnerid=25240&siteid=5341&Areq=65858BR