Senior Director, Research Compliance

Company: Harvard University
Location: Cambridge
Posted on: March 19, 2023

Job Description:

The incumbent represents the Chief Research Compliance Officer in managing operational and compliance-related activities, broadly. This will include directing the strategic and operational functions for Research Compliance within the Office of the Vice Provost for Research, including the Harvard Faculty of Arts and Sciences (FAS) and John A. Paulson School of Engineering and Applied Sciences (SEAS) Research Compliance Program (RCP). The RCP broadly covers areas of non-financial compliance including financial conflicts of interest and outside activities, export controls, and international collaborations and activities, data management, etc.Reporting to the University Chief Research Compliance Officer (CRCO) within the Office of the Vice Provost for Research (OVPR), the Senior Director of Research Compliance acts as the CRCO deputy with responsibility for overseeing all operational aspects of university-wide research compliance and management, the oversight and management of the research compliance function within the FAS and SEAS, and other related compliance activities delegated by the CRCO. A highly skilled individual with in-depth knowledge of the university research environment and the broad regulatory areas of research administration and compliance, the incumbent is capable of establishing and implementing effective research compliance policies, procedures, and guidelines, in accordance with the seven elements of an effective comprehensive compliance program pursuant to the Federal Sentencing Guidelines. This requires examining regulatory and agency policy requirements and working with the University-wide stakeholders including departments and schools under their operational compliance purview to assess the necessary approach and lead the development and implementation of an exemplary compliance program that is consistent with the University-wide policies as well as the compliance programs implemented at other schools. The incumbent represents the OVPR and the CRCO on a number of university-wide committees and is expected to engage at the national level, as a Harvard representative.Position DescriptionTo meet the needs of the Office of Research Compliance - and in addition to technical knowledge of the regulatory environment - coordination and communication are key functions of the Senior Director role with regards to planning, implementing, and monitoring the compliance program. Specific research regulatory activities cover a wide range of topics such as financial Conflicts of Interest in research, Export Control, protection of Human Subjects in Research, Animal Care and Use programs, Occupational and Environmental Health and Safety, Research Misconduct, Stem Cell Research, Research Data, and Privacy, International Research Compliance, etc., requiring close cooperation and coordination with multiple offices across the institution with operational responsibility with many of these activities. In service of these efforts, the Senior Director will supervise a small team, coordinating assignments and managing outreach to FAS and SEAS researchers and departments to manage relevant compliance tasks promptly and expertly. The range of activities includes, but is not limited to:

• Representing the CRCO in managing operational and other delegated activities across the institution.
• Collaborating with other offices and stakeholders across the University to facilitate effective policy development, implementation and management of compliance issues. The coordination and collaboration may include multiple stakeholders including School academic and departmental leadership, the Office for Sponsored Programs, the Office of Technology Development, and the Office of the General Counsel (OGC), and School based research compliance and administration offices;
• Coordinating internal compliance review and monitoring activities, including periodic reviews of policies and programs with relevant offices such as Risk Management and Audit Services (RMAS);
• Regularly reviewing and communicating changes to the regulatory landscape as they impact the research compliance functions and operations
• Developing, coordinating, and participating in a multifaceted educational and training program for both researchers and administrators that focuses on the elements of the compliance program, and that seeks to ensure that all appropriate employees and managers are knowledgeable about pertinent policies and federal and state standards;
• Participating in the investigation of matters related to compliance, including designing, and coordinating internal investigations (e.g., with Risk Management and Audit Services, School units, or OGC) and any resulting corrective action;
• Acting as a staff person for assigned University-wide committees reporting to, or ad-hoc committees appointed by, the OVPR;
• Serving as the OVPR representative on the Executive Operations Committee of the Research Compliance Program for FAS and SEAS;
• Managing the FAS and SEAS export control program to ensure compliance with U.S. Export Control regulations, including ITAR, EAR, and OFAC regulations;
• Serving as the Designated Institutional Official for the FAS and SEAS in delegated regulatory areas, overseeing the researcher and investigator outside activities and financial conflicts of interest disclosure process for all reporting individuals to ensure compliance with Federal conflict of interest regulations, sponsor requirements, and University policy;
• Developing policies, procedures, guidelines, and programs that enable the conduct of research by FAS and SEAS researchers while ensuring compliance with regulatory requirements and consistency with University-wide requirements and other School programs;
• Other duties as required.Basic Qualifications
  • PhD or J.D. required
  • Proven track record in developing and implementing effective research administration and compliance programs
  • A minimum of 15 years of experience in research administration and compliance in an academic setting with responsibility for researching with analyzing complex laws and regulations, agency policies, and other documentation
  • Thorough understanding of a broad spectrum of the regulatory and policy requirements related to research administration and compliance
  • Previous laboratory research experience may count toward years of experience.
  • Experience in supervising staff and processesAdditional Qualifications and Skills
    • Ability to assess existing university operations to determine the need for new or enhanced policies and procedures
    • Ability to support and promote an effective, ongoing regulatory compliance program; thorough knowledge of compliance issues, laws, and regulations relating to research compliance
    • Demonstrated ability to effectively communicate complex issues both verbally and in writing to diverse group of constituencies (e.g., leadership, faculty, staff, students)
    • Demonstrated highly effective interpersonal skills for working closely with internal organizational units and for the effective representation of organizational positions on issues with external parties and groups
    • Thorough knowledge of project management, operations analysis, and legislative work procedures
    • Ability to lead and manage projects
    • Ability to work independently on multiple issues concurrently and to exercise independent judgment in establishing priorities
    • Ability to organize work, make sound decisions, and exercise good judgmentAdditional InformationHarvard University supports a hybrid workplace model which will actively support some remote work. Specific days and schedules for on campus work and remote work will be discussed during the interview process. Please note hybrid workers must reside in a state where Harvard is registered to do business (CA, CT, GA, IL, MA, MD, ME, NH, NJ, NY, RI, VA, VT, and WA). Harvard University continues to place the highest priority on the health, safety and wellbeing of its faculty, staff, and students, as well as the wider community. Please note that all new employees will be required to provide confirmation of primary series COVID-19 vaccination upon hire, as detailed on our COVID-19 Vaccine Requirement Webpage . Harvard University Health Services employees and other health care individuals are also required to be up to date on vaccination as described by the CDC. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. Additional information regarding this requirement, exemptions, verification of vaccination status, and other related policies and resources may be found on the University's COVID-19 Information Website . Full Time. Monday through Friday. 35 hours per week. -Commitment to Equity, Diversity, Inclusion, and BelongingHarvard 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 StatementWe 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.

Keywords: Harvard University, Cambridge , Senior Director, Research Compliance, Executive , Cambridge, Massachusetts