The Compliance Officer shall oversee all ongoing activities related to the: 1) development, implementation, and maintenance of the Institute’s administrative and regulatory policies in accordance with internal guidelines and applicable federal and state laws and regulations; 2) LJI’s Conflict of Interest and Research Integrity policies, 3) LJI’s export control compliance program, and 4) LJI’s risk management function. In collaboration with LJI leadership, the Compliance Officer serves as a point of contact and institute liaison for federal agencies such as the Federal Bureau of Investigations, Department of Homeland Security, Department of State, and Department of Commerce.
Compliance Officer works to enhance compliance with applicable laws and regulations, administrative uniformity, and consistency through the revision and integration of institute-wide policies, procedures and guidelines. The Compliance Officer supports LJI’s internal operations and programs and will create, review, and revise policies to ensure programs and projects meet all legal and organizational requirements.
This position will also be responsible for risk administration functions and duties, including those identified by the Board of Directors and Executive Management. A principal activity will be the development and maintenance of an overall Institute risk “portfolio.” The portfolio will contain a prioritized list of risks, mitigation plans, and a current evaluation (by the Compliance Officer) as to the need to take further actions at the level of the Compliance Officer, LJI management, or the Board of Directors. The risk portfolio will be a regular component of reporting to LJI’s Audit, Risk and Compliance Committee.
As LJI’s Export Control Officer (ECO), Compliance Officer is responsible for designing, developing, implementing, and monitoring an effective export control program and communicating program requirements to the LJI community. The ECO is the primary point of contact for internal and external inquiries regarding export control compliance. The ECO advises the LJI community on export control issues related to international travel and shipments; reviews export control terms in non-routine proposals, contracts, and other agreements; applies for export control licenses when required; and maintains records in accordance with applicable requirements. The ECO also leads institute-wide initiatives to foster understanding and compliance with LJI’s export control requirements in a wide variety of research and business activities.
As requested, the Compliance Officer will provide assistance to the Technology Development office by reading, researching, interpreting, summarizing and preparing a variety of legal documents and filings related to intellectual property issues, and patent litigation, and general contractual matters.
The position will regularly provide guidance to LJI faculty and staff members, in addition to LJI’s Board of Directors, regarding compliance with LJI’s conflicts of interest policy, and conflicts of interest management plans, in addition to conducting compliance audits on behalf of the Institute. Will work with members of the Institute’s research community who are engaged in external relationships to ensure that all identified financial and institutional conflicts of interest are appropriately reported, evaluated and managed.
Responsibilities and Duties
o Works independently and with LJI’s management to enhance and document internal processes and policies.
o Develops policy and implementation guidance; performs legislative and regulatory analysis; and coordinates interdepartmental policy and procedures.
o Works collaboratively with management to achieve program results.
o Develops recommendations on policy positions, including analyzing data and requesting and evaluating qualitative and quantitative information, from internal and external sources.
o Collaborates, when necessary, with outside entities for policy development and implementation.
● Risk Management
o Manage a prioritized portfolio of LJI’s risks. Develop a strategic plan to mitigate risks in collaboration with LJI management and its Board of Directors.
o Develops, maintains, and executes an internal audit function that evaluates the effectiveness of risk management plans.
o Works proactively and collaboratively with LJI departments to ensure LJI’s adherence to regulations that govern use of federal funds through a best practices approach.
o Works proactively and collaboratively with LJI departments to ensure LJI’s adherence to regulations and agreements relevant to non-federal funds through a best practices approach.
o Provide recommendations to LJI’s executive management and/or Audit, Risk and Compliance Committee to address findings and/or concerns.
● Conflict Review Officer (CRO)
o Acts as Conflict Review Officer for the Institute.
o Responsible for management of overall documentation of LJI policies relating to Employee Conflicts of Interest policy, and the Board of Directors Conflicts of Interest policy; oversees management of specific conflict of interest policy development, implementation guidance, and relevant legislative and regulatory analysis.
o Distribute, collect, and review all ad hoc or annual Conflict of Interest Disclosure forms (pursuant to the general Conflict of Interest policy) including disclosure of other outside professional activities to all LJI investigators, directors, administrative heads, and others as determined appropriate. This includes requirements to ensure any and all support from foreign entities is completed consistent with requirements, in particular those of the Federal government.
o Provides assurance that conflict of interest training programs educate all LJI employees regarding relevant policies and procedures, and that LJI employees are compliant with attendance at training programs.
o Interacts with administrative units at other research institutes regarding regulatory changes in conflicts of interest policy.
o Works proactively and collaboratively to ensure LJI’s adherence to regulations that govern use of federal funds.
o Responsible for developing, implementing, and maintaining the Conflicts of Interest procedures and/or systems, as well as training related to its use for disclosure of financial interests and commitments, travel, and federally required training.
o Responsible for reviewing and approving all Outside Professional Activities for employees, including agreement review and finalization incorporating LJI’s Uniform Consulting Agreement Provisions.
o Communicate information regarding conflicts of interest policies and procedures to faculty and staff.
o Conduct periodic audits and assist in compliance assessments.
o Assists LJI faculty, staff, and Directors in the disclosure process.
o Develops and monitors conflicts of interest management plans.
o Communicates findings of conflicts of interest review to faculty members, including determinations of eliminating, reducing, or managing identified conflicts of interest.
o Refer concerns to, and collaborate with, LJI’s Executive Management, Audit, Risk and Compliance Committee and outside counsel.
o Present compliance reports to LJI’s Audit, Risk and Compliance Committee as requested.
● Research Integrity Officer (RIO)
o Administer policies and procedures associated with research integrity and research misconduct.
o Evaluate allegations of misconduct related to research at LJI in accordance with applicable Institute policies and applicable sponsor and governmental regulations/requirements.
o Coordinate investigations and resolve promptly, fairly, and confidentially (to the extent reasonably possible) all instances of alleged or apparent research misconduct.
o Assure adherence to LJI policies by providing tools, guidance, and oversight needed to promote a clear understanding of the principles of scientific integrity.
o Develop and lead proactive activities within the LJI community to ensure institutional compliance with applicable laws and regulations and to promote ethical behavior and research integrity.
● Export Control Officer (ECO)
o Design and manage policy and internal processes in compliance with Federal Export Control regulations.
o Advise on regulatory requirements and provide input to faculty and administration for handling complicated export control situations.
o Conduct periodic audits to assess compliance with Federal Export Control regulations.
o Design and deliver a variety of educational and training materials tailored for different audiences across campus, including faculty, staff, and students.
SCOPE AND COMPLEXITY
Works independently with general directions on routine duties and detailed instruction on unique tasks.
SUPERVISION OF OTHERS
Individual contributor. Does not supervise.
● Juris Doctorate (J.D.) or Master’s degree in Science, Business, Health Care, Compliance, or comparable professional certifications.
● Additional emphasis/training/education in bioethics, health, law, executive public administration or related scientific discipline.
● Expert knowledge in federal and state laws, regulations, and guidance relating to research and related areas.
● Demonstrated knowledge of conflict of interest regulations and requirements in a research institute setting.
● Demonstrated experience with research integrity and compliance programs, conflict of interest principles, and working knowledge of related federal laws and regulations.
● Experience or training as a Research Integrity Officer (RIO) or research compliance role.
● Experience in developing and conducting education and training programs in research compliance and integrity.
● Experience with Intellectual Property and Research Compliance.
● Ability to work independently and as part of a team.
● Excellent research and analytical skills.
● Excellent verbal and written communication and interpersonal skills.
● Ability to interpret complex policies and provide guidance to the LJI community.
● Excellent interpersonal and collaborative skills, along with the ability to interact effectively with a diverse constituency.
● Ability to maintain a high level of discretion and confidentiality.
● Organizational and prioritization skills, along with the ability to work within tight and conflicting deadlines and a willingness to work extended hours/weekends as necessary.