Employment History Include your last ten (10) years of employment history, or length of your employment history if less, including all positions (even those that are not relevant to this position) and periods of unemployment.
The Director of Research Compliance and Integrity (RCI) is responsible for the creation, development, and implementation of policies and procedures, as well as oversight of the Institute’s overall research compliance and integrity program. In collaboration with other relevant departments, the Director ensures the continuous adherence to all laws, rules, and requirements governing the Institute’s research.
Manages and administers all policies and procedures associated with the Institute’s Conflict of Interest, Outside Activities, Conflict of Commitment, Research Misconduct, and Export Control compliance programs. Partners with other departments to ensure compliance related to human and animal subjects. Provides oversight and management of research compliance for all types of research support and all sponsors, including public and private grants, contracts, subawards and other agreements. Provides expert advice on compliance related issues to leadership and other departments.
Trains faculty and staff on regulatory compliance matters to enhance understanding and awareness throughout the organization. Provides direction, education, and support to the Institute with respect to fiduciary and regulatory compliance activities.
(40%) Compliance Program Oversight
- Manages and administers all policies and procedures associated with the Institute’s Financial Conflicts of Interest, Outside Activities, Conflict of Commitment, Research Misconduct, and Export Control compliance programs.
- Coordinates with other relevant departments to ensure compliance related to human and animal subjects.
- Provides expertise and administrative support to the Institute’s Research Integrity Officer.
- Serves as the Institute’s liaison and the main point of contact with all federal agencies and regulatory bodies as they relate to compliance, whether building relationships or responding to queries.
- Serves as a resource for research compliance and integrity questions concerning the interpretation of policies and their application to individual circumstances.
- Maintains ongoing expertise in federal and other relevant regulatory policies.
- Identifies new compliance related requirements and develops policies and procedures to ensure the Institute’s adherence.
- Leads and implements changes to policy and procedures across departments; works with department heads to ensure changes are implemented and monitored.
- Monitors and tests the Institute’s policies and procedures to determine their adequacy and effectiveness.
- Provides guidance to faculty, staff, and Institute leadership on developing and maintaining a strong institutional compliance framework.
- Monitors all relevant guidelines and interprets the impact on Institute operations, reporting potential concerns and opportunities and recommending appropriate actions.
- In collaboration with other relevant departments, maintains systemic records of the Institute’s compliance programs.
- Reviews and provides recommendations to relevant Institute staff on agreements that have compliance implications.
- Provides information to and assists the General Counsel with risk assessment and mitigation.
- Serves on relevant compliance committees.
(30%) Research Compliance Monitoring
- Monitors ongoing compliance with the Institute’s Conflict of Interest, Outside Activities, Conflict of Commitment, Research Misconduct, and Export Control programs and other general research compliance activities.
- Serves as the Designated Institute Official for reviewing Investigator Conflict of Interest Disclosures, including reviewing disclosures prior to the start of awards.
- Plans and executes projects (including internal investigations in conjunction with legal counsel) to help validate that research activities are conducted in accordance with all applicable federal and state laws and regulations, system policies, and rules and procedures. Identifies areas of concerns and implements actions to mitigate risk.
- In collaboration with other departments, ensures congruence between grants and human and animal protocols.
- Provides support to the Subawards and Contracts Specialist in developing, reviewing, redlining, and negotiating contracts, subcontracts, and other agreements particularly with regard to how the agreements will impact the Institute’s compliance efforts.
- Clearly communicates with applicable departments their role as it relates to the compliance requirements outlined in the award. Partners with subject matter experts to create internal policies and procedures to ensure compliance and clearly communicates with faculty regarding their obligations.
- Provides expertise in reporting and closeout of federal contracts and other agreements.
- In collaboration with the Subawards and Contracts Specialist and other departments, ensures compliance with FAR, DFARS, and other relevant regulations and agreement terms and conditions.
(30%) Building a Culture of Compliance
- Develops and implements a strategic plan to increase awareness of research compliance and integrity issues and policies.
- Identifies and communicates need for compliance education programs and helps to oversee the development and implementation of compliance training across the organization.
- Develops, implements, and provides tools facilitating employee adherence to research compliance and integrity policies.
- Trains faculty and staff on regulatory compliance and integrity matters to enhance understanding and awareness throughout the Institute. Develops compliance training materials.
- Conducts Institute-wide communications related to compliance.
- Minimum 7 years of relevant experience, of which at least 3 years leading a broad research and integrity compliance operation. Equivalent combination of education and experience will be considered.
- Demonstrated success in implementing policies to ensure compliance with biomedical research regulations.
- Experience with NIH, NSF, and DOD compliance requirements.
- Experience working across departments to ensure a distributed compliance infrastructure is successful.
- Extensive experience with contract and grant policies and issues and with external funding programs and requirements relevant to major sponsors of biomedical research, e.g. NIH, NSF, DOD, CIRM.
- Experience in an academic or non-profit research institution.
- Relevant government or research compliance experience.
- Experience managing and leading personnel.
- Bachelor’s degree in relevant scientific or engineering discipline or equivalent experience
- PhD in a relevant scientific or engineering discipline
- JD or relevant government or law enforcement experience
SKILLS AND ABILITIES
- Extensive knowledge of relevant laws, policies, and guidelines regulating biomedical research, including the NIH Grants Policy Statement and the NSF Proposal & Award Policies & Procedures Guide.
- Knowledge of laws, policies, and guidelines governing Financial Conflict of Interest, Outside Activities, animal and human subjects, Conflict of Commitment, Research Misconduct, and Export Control compliance programs, including specific knowledge of ITAR/EAR, FARS/DFARS, and IACUC.
- Demonstrated leadership ability and management skills, including managing research compliance and integrity activities, developing new policies and procedures, and promoting a positive and collaborative research environment.
- Strong interest in and ability to quickly comprehend Salk scientific research programs and the impact of compliance issues on Salk research.
- Advanced skills in researching and analyzing research compliance laws, policies, and issues.
- In-depth knowledge of functional areas that administer and/or are impacted by research compliance and integrity issues, including Grants Administration and Research Accounting.
- Sound understanding of the role of research in a major research institute along with substantial experience in performing complex analyses on policies or programs related to research compliance.
- Extensive knowledge of contract and grant policies and issues and external funding programs and requirements, including knowledge of national and international trends in scientific research.
- Demonstrated strategic and creative thinking skills to anticipate a changing regulatory landscape and to translate that thinking into cogent plans for a large and diverse institute.
- Leadership and management skills, including problem solving, negotiation, decision-making, research and analysis, and interpersonal skills. Ability to organize, manage, and inspire professional staff while conceptualizing, planning and implementing programs that support research, and ability to ensure accountability and compliance.
- Excellent interpersonal communication skills to establish and maintain professional, collaborative working relationships with widely diverse groups, including faculty, executive management, senior academic and administrative officers, Institute development and communication departments, and external contacts.
- Demonstrated skill in written communications that employ grammatically correct English and express complex medical, scientific, and/or technical content concisely and logically and in understandable terms.
- Strong organizational skills and ability to independently manage multiple projects with conflicting deadlines and priorities. Ability to meet deadlines. Ability to work with minimal direction, on a self-directed basis, and as a member of a team.
- Demonstrated ability to appropriately handle highly sensitive and confidential situations and matters involving faculty, staff, and representatives of external organizations.
SPECIAL CONDITIONS OF EMPLOYMENT
- Must be willing to work in an animal-related research environment.
- Must be willing to work an adjusted schedule to support research needs.
- Successful completion of the Institute’s background investigation.
- Must be willing to sign confidentiality agreement.
PHYSICAL REQUIREMENTS/MENTAL ACTIVITIES/ENVIRONMENTAL CONDITIONS
This position will be constantly seeing, sitting and working inside.