Associate Director, Research Training and Compliance

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About Queen’s University

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Job Summary
Reporting to the Director, Research Compliance, the Associate Director Research Compliance and Training is a key member of the Vice-Principal Research (VPR) portfolio leadership team and is responsible for overseeing and managing various activities related to regulatory compliance in research. The individual will manage a team and lead initiatives to develop new research policies and procedures; develop a comprehensive research compliance framework that meets all applicable laws and regulatory requirements; develop training and educational activities and resources; and ensure high standards of excellence in operations with regulatory and other compliance accountabilities of the research enterprise at Queen’s University compliance with various guidelines.

The Associate Director works collaboratively with other members of the research portfolio, various units across the university and affiliated research hospitals (e.g. Kingston Health Sciences Centre) and the Kingston General Health Research Institute to develop and advance research compliance. Compliance issues may include but are not limited to research security, research data management, clinical trials management, data privacy, conflict of interest, research integrity, and safeguarding intellectual property. The Associate Director participates in, and is sometimes responsible for, long-term planning, development and implementation of these activities. This role also oversees a small team with expertise in research ethics quality assurance and educational programming.

This role will require strong collaboration with faculty, researchers, and other administrative staff to facilitate and promote a culture of compliance within the research community.
Job Description

KEY RESPONSIBILITIES:

• Develop and manage the quality assurance and research compliance oversight programs for human participant research to ensure adherence to applicable laws, regulations, and policies governing research.
• Develop a comprehensive research compliance framework that meets all applicable laws and regulatory requirements.
• In collaboration as appropriate, actively review, create, and/or implement of a variety of institutional policies and procedures related to research compliance; lead the finalization of policies, guidance documents, standard operating procedures and templates relating to research activities; ensure all processes and documents are consistent with external standards, including applicable laws, regulations, and industry requirements.
• Remain abreast of regulatory changes and provide advice regarding policy, procedural, and resource/operational needs relative to existing and emerging areas of research compliance.
• Work with others to develop standard operating procedures to ensure compliance with national, provincial, local, and institutional requirements.
• Implement measures to ensure that members of the Queen’s research community are properly informed about all policies, procedures, and regulatory requirements relevant to research compliance.
• Oversee the development of educational programming for faculty, staff, and students; ensure the provision of related resources to aid the Queen’s research community in conducting research to the highest standard.
• Provide substantive leadership on all matters related to research compliance involving human subjects’ protection.
• Actively participate in compliance matters led by other units. Such matters may include research misconduct and responsible conduct of research; research-related conflicts of interest and commitment; data use agreements and data management plans; research security, and foreign engagement.
• Provide regular updates to the Director on issues of non-compliance reported, identified, and resolved at Queen’s University.
• Manage annual action plans, monitor progress, and report on performance.
• Acquire and leverage deep knowledge about leading and emerging research and best practices that support Queen’s research goals and strategies.
• Accountable for ensuring a positive and productive working environment consistent with the vision and values of the Vice-Principal Research portfolio and the University’s commitment to equity, diversity and inclusion.
• Provide leadership related to national and international regulations and compliance.
• Represent the compliance and training arm within the VPR portfolio, communicating effectively with other networks and collaborators.
• Develop long and short-term operational planning for all regulatory, monitoring, audit and training activities and handle complex issues in the conduct of research.
• Oversee participation of Queen’s with regulatory agencies and others regarding Queen’s compliance. Represent Queen’s and communicate effectively with regulatory authorities, networks and collaborators (including industry). Ensure official responses to inquiries from these stakeholders are comprehensive and meet stakeholders’ needs.
• Undertake additional duties in support of the training and compliance unit.

Human Resources Management:

• Plan, prioritize and manage employees’ work, providing strategic and tactical advice, guidance and coaching. Identify the need for staff resources, participate in staffing committees, and make effective recommendations regarding employee selection.
• Manage performance by establishing performance standards, reviewing and evaluating performance and conducting formal performance reviews on an ongoing basis.
• Assess staff training and development needs and ensure employees receive training to improve and sustain successful performance.
• Investigate, address and resolve employee/labour relations issues, including disciplinary matters. Make decisions or effective recommendations on possible discipline, discharge and probationary termination.
• Promote a culture of inclusion, with a commitment to the university’s equity, diversity, accessibility, and inclusion initiatives designed to foster an inclusive, supportive, and welcoming work environment for individuals with diverse backgrounds and identities.
• Oversee the development and delivery of training activities for new staff, researchers, and others.

REQUIRED QUALIFICATIONS:

• A thesis-based master’s degree in a health sciences and/or research methodology field.
• Five to seven years experience in one of more of the following: human participant research, clinical trials management, higher education research support, law, research compliance.
• Experience interfacing with regulatory authorities and health care institutions that conduct research.
• Sophisticated knowledge of government and sponsor regulations and requirements for research compliance, including the regulations and guidelines governing clinical research and research ethics (i.e., the protection of human research participants), including those articulated by the Tri-Council Policy Statement, Health Canada, the International Conference on Harmonisation (ICH) Good Clinical Practice, US Food and Drug Administration and the US Office for Human Research Protections, and privacy legislation.
• Training and experience in Quality Control and Quality Assurance.
• Experience leading and managing a team.
• Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:

• Respect for diversity and promotion of inclusion in the workplace.
• Expertise with regulatory requirements, and compliance / ethical standards.
• High level of organizational, administrative, project facilitation and management skills with a demonstrated ability to meet deadlines in a collaborative, fast-paced, client-oriented environment.
• Ability to execute proposed actions within predetermined timelines against organizational goals and with consideration of the competitive landscape in which the department/organization operates. Strong planning skills to develop and integrate departmental plans to achieve the overall organization’s goals.
• Ability to lead and motivate others and cultivate high-level performance within a high-functioning team environment to maximize faculty members’ research and scholarship potential.
• Strong analytical and problem-solving skills with an ability to compile, synthesize and interpret relevant information from various sources and pay exceptional attention to details.
• Well-developed interpersonal skills to work collaboratively with various stakeholders and manage a team in a fast-paced and dynamic work environment.
• Excellent communication skills (both written and verbal) to interact with a diverse group of individuals professionally.
• Managerial and supervisory skills, including delegation of graduated degrees of responsibility, mentorship and conflict resolution.
• Ability to collaborate and liaise with others to develop plans and implement policies and procedures, including developing and overseeing project management activities.
• Ability to work in a very confidential environment.
• Advanced computer skills, including Word, Excel, PowerPoint, and knowledge of database structures.
• Ability to provide judgment in interpreting complex regulations regarding research activity.

DECISION MAKING:

• Determine best action to streamline and increase research processes and practices’ efficiency, effectiveness, responsiveness and accountability.
• Determine development and support requirements, and contribute to developing strategic plans and objectives.
• Determine strategies for staff and faculty training.
• Plan, implement, and evaluate administration policies, procedures, and practices to meet university, division, portfolio, and unit goals and priorities.
• Decide when to escalate decisions, challenges or unresolved issues to the Director and/or senior leaders.
• Assess and interpret policies associated with research collaborators, including the pharmaceutical and biotechnology industry, with respect to application and adoption.
• Set priorities and oversee staff workload, including determining required training and communications.
• Evaluate, recommend, and offer expert advice on developing and implementing technological or process-related improvements, integrations and initiatives.
• Determine when to advise the Director of a situation that might impact negatively or positively on the university and formulate recommendations for mitigation or pursuing an opportunity.
• Evaluate employee performance and decides on appropriate training or coaching to address lack of proficiency in carrying out responsibilities or remedial action for staff disciplinary situations.
• Evaluate job candidates and makes effective recommendations on suitable hires.
• Make decisions and/or effective recommendations regarding transfers and promotions.
• Assess the investigation outcome of grievances and make effective recommendations on the appropriate course of action or next steps.
• Makes effective recommendations on the level of discipline up to discharge and probationary termination.
• Determine the manner and content of official replies to regulatory authorities.

Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queen’s is committed to employment equity and diversity in the workplace and welcomes applications from women, visible minorities, Aboriginal Peoples, persons with disabilities, and persons of any sexual orientation or gender identity. In accordance with Canadian Immigration requirements, priority will be given to Canadian citizens and permanent residents.
The University provides support in its recruitment processes to applicants with disabilities, including accommodation that takes into account an applicant’s accessibility needs. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at hradmin@queensu.ca .