Exciting CITI News!

N2 is pleased to announce the release of the ICH E6 R2-GCP updated Good Clinical Practice (GCP) Basic Course. The 10-module course is now available through the Collaborative Institutional Training Initiative (CITI).

Previously 13-modules, this 10-module course discusses good clinical practice as it relates to clinical trials. The discussion is focused on the International Council for Harmonisation (ICH)-E6 (R2) guidelines and applicable regulations in Canada such as Health Canada-Division 5, and The Tri-Council Policy Statement 2.

This is significant in that N2 has worked with TransCelerate to assure that the high-quality CITI Canada GCP course accessible to N2 members meets their standards. This means if you are working with a TransCelerate affiliated company you can assure them that your CITI Canada training has formal approval and recognition from TransCelerate. Meeting TransCelerate training criteria is the latest milestone in a trend that has seen many biopharmaceutical companies as well as research networks, hospitals and universities accept the CITI Canada GCP course as their gold standard.

For more information please review the article “How to Determine if a GCP Course Meets TransCelerate BioPharma Minimum Criteria” which provides a brief overview of the TransCelerate certification.

For more CITI updates please click here.

Knowledge Mobilization & Research Impact Specialist

About Western

With an international reputation for success, Western ranks as one of Canada’s top research-intensive universities. Our research excellence expands knowledge and drives discovery with real-world application. Western also provides an exceptional employment experience, offering competitive salaries, a wide range of employment opportunities and one of Canada’s most beautiful campuses.

About Us

Western ranks as one of Canada’s top research-intensive universities. With contributions that range from fundamental research to applied discovery, its researchers advance knowledge and provide tangible benefits for the economic, social, health and cultural development of citizens in London, in Canada, and around the world. Western Research provides strategic and comprehensive support to foster a culture of research excellence that enhances Western University’s profile on the global stage.

Responsibilities

The Knowledge Mobilization & Research Impact Specialist’s primary mandate is to maximize Western’s research impact by building capacity, connections, and a community that prioritizes excellence in discovery with innovation in research mobilization and dissemination. The role will support strategic initiatives to build a framework and culture of inclusive research assessment that better profile the breadth of research and research impact at Western. The Specialist will identify and develop strategic relationships locally, nationally facilitate the removal of barriers to research knowledge by training, empowering and supporting Western faculty, staff and students on the implementation of strategic plans for mobilizing research outcomes and supporting research partnerships. The role will assist directly with knowledge user and partner identification and engagement, funding opportunity dissemination and support, research proposal development, implementation of internal initiatives and programming, and the curation of resources to support innovative mobilization, research co-creation, and research impact. The overarching purpose of the role is to enhance Western’s research success and funding performance.

Qualifications

Education:

  • 4 year undergraduate thesis-based degree
  • Certificate in knowledge translation/mobilization
  • Graduate degree in a research-based discipline preferred
  • Courses in quantitative and qualitative analysis preferred

Experience:

  • 5 years’ experience supporting knowledge mobilization and research assessment practices within a post-secondary environment
  • 1 year experience supporting grant proposals
  • Proven experience writing successful proposals and working with major government research programs is preferred
  • Experience preparing presentations, workshops, toolkits and/or resources related to knowledge mobilization and research impact assessment is preferred
  • Knowledge of open access, open science, inclusive and responsible research assessment practices, bibliometrics preferred
  • Certificate and/or completed training related to cultural safety preferred

Knowledge, Skills & Abilities:

  • In-depth knowledge of best practices for knowledge mobilization and inclusive research assessment
  • In-depth knowledge of Canadian peer-review granting systems, funding landscape and knowledge mobilization requirements 
  • Demonstrated ability to develop and deliver educational sessions and resources to diverse stakeholders to increase their awareness of, and capacity for, knowledge mobilization, research dissemination, partnered research and research impact assessment
  • Persuasive oral and written communication skills, plain language skills and critical thinking skills to translate information into easily understood terms, summarize information, and provide a rationale for action
  • Passion for supporting and elevating research Proficiency in program management and mixed-methods evaluation
  • Experience in event planning and coordination
  • Advanced computer skills in Microsoft Office Suite
  • Ability to research new avenues of funding from federal granting agencies, industry and other funding sources
  • Strong editing and proofreading abilities with attention to detail with emphasis on requirements for proposal development, reports and presentations
  • Superior time management and organizational skills to create and maintain required processes and meet deliverables
  • Influential interpersonal skills to interface with stakeholders, build relationships and network
  • Ability to analyze and synthesize sizable amounts of detail/data with an ability to communicate information to academic and non-academic audiences using different approaches
  • Ability to work collaboratively with diverse stakeholders to inform work goals, advance work independently, and share openly
  • A well-defined sense of diplomacy, solid negotiation and facilitation skills
  • Proven ability to work well with diverse groups at all levels within the institution and external parties, exercising appropriate judgment in decision making
  • A desire to grow and advance skills, which is demonstrated by attending conferences, workshops and other professional developmental opportunities to enhance performance

 

Western Values Diversity

The University invites applications from all qualified individuals. Western is committed to employment equity and diversity in the workplace and welcomes applications from women, members of racialized groups/visible minorities, Indigenous persons, persons with disabilities, persons of any sexual orientation, and persons of any gender identity or gender expression.

Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please contact Human Resources at hrhelp@uwo.ca or phone 519-661-2194.

Ethics Compliance Advisor at Queen’s University

COVID 19 On-Campus Requirements

Prior to May 1, 2022, the University required all students, faculty, staff, and visitors (including contractors) to declare their COVID-19 vaccination status and provide proof that they were fully vaccinated or had an approved accommodation to engage in in-person University activities. These requirements were suspended effective May 1, 2022, but the University may reinstate them at any point.

About Queen’s University

Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.

We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.

Come work with us!

Job SummaryA Brief Overview
This position oversees the administration of the Quality Assurance Monitoring programs for research involving human participants. This position ensures that research being conducted is in accordance with applicable guidelines and internal/external Standard Operating Procedures, as well as develops and facilitates training of of SOPs to the research community. The position also supports the activities of the research ethics boards to ensure the necessary processes are in place to support ethics audits by external agencies.This position oversees the administration of the Quality Assurance Monitoring programs. This position develops and facilitates training of new Standard Operating Procedures (SOPs) that are aligned with external ethics guidelines, policies, and regulations. This position delivers presentations to educate on ethical guidelines and ensures continuous quality assurance.

Job Description

What you will do

  • Oversees the overall administration of the Quality Assurance Monitoring program.
  • Develops and maintains compliance processes.
  • Ensures SOPs are consistent with applicable external ethics guidelines, policies, and regulations.
  • Develops and facilitates training of new SOPs.
  • Develops supporting documentation such as website content.
  • Works with ethic committees to improve operations and increase compliance.
  • Ensures that the Research Ethics Boards (REBs) practices are consistent with applicable external ethics guidelines, policies, and regulations.
  • Delivers presentations to educate and ensure continuous quality improvement.
  • Develops and promotes procedures and tools to support efficiency and compliance.
  • Conducts mock audits to ensure research being conducted follows protocol and local regulations and international ethical guidelines.
  • Verifies compliance and consistency with internal standards and national regulations.
  • Prepares reports for ethics boards’ functions.
  • Assembles annual reports for budgeting.
  • Other duties as required in support of the department and/or unit.

Required Education

  • Master’s Degree or equivalent. In addition, requires a professional designation, certification, or other qualification, or on-going learning to remain ahead of changes in technology or emerging fields.

Required Experience

  • More than 5 years of experience.
  • Consideration may be given to an equivalent combination of education and experience.

Job Knowledge and Requirements

  • Knowledge of concepts and principles in a specialist field that is typically acquired through a combination of advanced professional or academic qualifications and/or significant work experience.
  • Provide expert advice, guidance and consultation on highly complex issues and/or where the outcome may be contentious.
  • Interaction with others requires highly developed interpersonal skills to effectively persuade, negotiate, counsel, and/or consult.
  • Adapt messages to meet the different needs of different audiences.
  • Prioritize and distribute work to deliver objectives on time and to the highest standard.
  • Identify in advance when the intended results may not be achieved and develops a plan to address the gaps.
  • Lead team and project meetings and develop team/unit and departmental project plans.
  • Lead procedural or technological change within a unit or across broader university functions.
  • Identify opportunities to improve the effectiveness and efficiency of work processes.
  • Anticipate complex challenges to ensure activities are completed on time.
  • Effectively leverage relevant data as input to making decisions.
  • Appropriately assess risks before making a decision.
  • Comprehensive understanding of what sexual violence, harassment and discrimination are, and their varying effects on diverse members of the community.
  • Question and take appropriate steps to address attitudes, macroaggressions and other behaviours which are discriminatory. Acknowledges and respects diverse cultural traditions, abilities and beliefs.

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.

Clinical Trial Monitor at Maternal Infant Child & Youth Research Network

Position Summary

The Maternal Infant Child and Youth Research Network is a federal not-for-profit, charitable organization founded in 2006 to build capacity for high-quality applied health research. It currently links 21 maternal and child health research organizations based at academic health centres in Canada and is affiliated with more than 25 practice-based research networks of investigators from across teaching hospitals which are affiliated with the 17 medical schools in Canada. MICYRN’s principal role is to improve the quality and impact of research through the provision of a coordinated infrastructure to support research teams working across Canada and beyond. In support of the clinician-scientists and clinician-investigators in the maternal, perinatal, and child health research space, MICYRN has acquired the expertise to function as a de-centralized Academic Research Organization (ARO).

MICYRN is seeking a Clinical Trial Monitor (CTM), responsible for Monitoring and Quality Assurance for complex national/international clinical trials and research projects, both academic and industry sponsored, in the maternal and child health space. The CTM will conduct monitoring activities across multiple Canadian sites in accordance with trial protocols and procedures, organizational and Sponsor SOPs, ICH-GCP, and applicable regulatory requirements. The CTM will be available to travel regularly (up to weekly) within Canada to support project monitoring and quality assurance needs. The CTM will liaise and build strong and co-operative relationships with multicentre investigators and their teams. The CTM will work closely with the MICYRN Clinical Trial Monitoring Lead (CTML), supporting organizational Quality Assurance initiatives and Cross Institutional Monitoring Program needs, as necessary. The CTM will report to the MICYRN Director of Operations, with functional supervision from the Associate Director, Clinical Trials. The estimated FTE required is approximately 10-20 hours per week, with the possibility to grow into a full-time position.

The successful applicant must reside within Canada (Canadian Citizen or Permanent Resident). MICYRN is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, Métis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and organization to apply.

Responsibilities

  • Conduct on-site and remote monitoring activities in accordance with protocols, monitoring plans, organizational and Sponsor SOPs, ICH-GCP, and applicable regulatory requirements.
  • Establish strong working relationships with a diverse group of clinical trial sites, investigators, and key stakeholders.
  • Perform site Selection/Initiation/Intermittent/Close Out visits to ensure protocol adherence, regulatory compliance, REB compliance, data integrity, timeliness and quality, safety reporting, investigative product accountability and storage, Investigator Site File (ISF) maintenance, adequate site facilities, and overall compliance with research conduct.
  • In collaboration with the CTML, develop and adhere to risk-based Clinical Monitoring Plans, SOPs, tools and templates; participate in assessing project status and risk, as applicable.
  • In collaboration with the CTML, participate in organizational QA activities, as applicable.
  • Prepare monitoring visit reports and communicate findings appropriately; identify and escalate non-compliance and poor performance to relevant MICYRN and Sponsor stakeholders.
  • Prepare for and participate in regulatory/Sponsor inspections and audits, both within the organization and across investigational sites.
  • Support MICYRN Cross Institutional Monitoring Program needs, as necessary.
  • Participate in meetings and ongoing training requirements, as required.
  • Conduct other Quality Assurance duties, as required.

Qualifications

  • Undergraduate degree, preferably in a health-related discipline (Essential)
  • Clinical Research Professional training/licensure (eg. ACRP, SoCRA) (Essential)
  • Minimum of 5 years clinical trial monitoring and QA experience, industry-focused (Essential)
  • Previous experience within the maternal and child health setting (Asset)
  • Experience with local, central, and harmonized ethics boards requirements (Essential)
  • Knowledge and experience with data management and clinical trial databases (Essential)
  • Training and in-depth knowledge of ICH-GCP, Regulatory Requirements (Health Canada) (Essential)
  • Familiarity with international clinical research guidelines, laws and standards (FDA, EMA) (Asset)
  • Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) and videoconference tools (Zoom, Microsoft Teams) (Essential)
  • Demonstrated productivity and self-motivation in remote/hybrid work environments (Essential)
  • Superior communication skills (written, oral and presentations) (Essential)
  • Excellent problem solving, critical thinking and conflict-resolution skills (Essential)
  • Exceptional attention to detail, organizational skills, and ability to prioritize multiple projects and tight deadlines (Essential)
  • Ability to function both independently and within a team (Essential)
  • High degree of professionalism and strong ability to build relationships (Essential)
  • Ability to travel within Canada regularly (up to weekly as needed) (Essential)
  • Physical ability to carry out the duties of the position (Essential)
  • Bilingualism (French / English) (Asset)

 

Interested candidates should submit a cover letter of interest and curriculum vitae to Karin Kushniruk, Associate Director, Clinical Trials by email: karin.kushniruk@micyrn.ca

Deadline for submission of applications is December 8, 2023.

CHEER Project Manager

COVID 19 On-Campus Requirements

Prior to May 1, 2022, the University required all students, faculty, staff, and visitors (including contractors) to declare their COVID-19 vaccination status and provide proof that they were fully vaccinated or had an approved accommodation to engage in in-person University activities. These requirements were suspended effective May 1, 2022, but the University may reinstate them at any point.

 

About Queen’s University

Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.

We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.

Come work with us!

 

Job Summary

Reporting to the Nominated Principal Investigator, the CHEER Project Manager will be responsible for the overall management of a five-year Canadian Institute of Health Research (CIHR) funded research project, the Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER). The project is focused on streamlining research ethics review and providing research ethics education for child health research across Canada. The incumbent will manage the implementation of the project including the overall project plan and activities, budget management, financial accountability, reporting, events/meeting coordination, and communications. The CHEER project manager will lead and supervise teams and working groups, supervise administrative support team members, and manage the hiring process for all incoming employees and contractors for CHEER. The incumbent will also present results, including preparing reports to the funder (CIHR), drafting and reviewing publications, and developing and delivering presentations at meetings and conferences. The CHEER Project Manager will contribute to completion of project deliverables and will ensure effective communication across the broad CHEER team and committees.

Job Description

KEY RESPONSIBILITIES:

  • Support the CHEER leadership in meeting the deliverables of the CHEER project, contributing to the development and implementation of a Canada-wide streamlined research ethics review program, a Research Ethics Board assessment program and educational resources.
  • Lead and supervise teams and working groups contributing to the deliverables of the CHEER project. These teams and working groups include: the CHEER Research Ethics Board (REB) qualification team, MICYRN (Maternal Infant Child and Youth Research Network) national clinical trial navigators, and other groups as appropriate.
  • Manage the CHEER REB Qualification Program; Supervise the CHEER REB qualification team members, which involves establishing and managing teams of 5 research ethics experts conducting on-site qualification visits; oversee the preparation and finalization of high-quality reports that are compliant with the established qualification manual and process.
  • Establish performance standards, review and evaluate performance and contribute to conducting formal performance reviews on an ongoing basis.
  • Assess staff training and development needs and ensures that employees receive training required to improve and sustain successful performance.
  • Assist in developing educational content, policies, processes, training resources and tools to support project deliverables.
  • Provide expert level guidance and advice to the PI regarding design and implementation of research strategy.
  • Manage the hiring process for all incoming employees and contractors to the CHEER project, including selection and employment and contract negotiations.
  • Manage the quality assurance program and ensure all CHEER deliverables fulfil grant objectives and are completed on time.
  • Work closely with the lead organizations, Clinical Trials Ontario (CTO) and the Maternal Infant Child and Youth Research Network (MICYRN), as well as the Queen’s University Office for the Professional Development and Educational Scholarship (OPDES) to support the development and implementation of project deliverables.
  • Develop, maintain and monitor a detailed project management timeline and task set; work with the team and committees to set priorities and project objectives.
  • Develop the project budget and be responsible for monitoring and reporting, as per funder/institution guidelines, and in coordination with the Departmental Administrator in Public Health Sciences; liaise with the lead groups.
  • Oversees the data collection required for evaluation of key metrics and synthesizes data, complies data into reports, databases, manuscripts, and presentation tools.
  • Lead and conduct information gathering exercises as needed, including literature reviews, web searches and outreach; prepare background documents and other materials needed to advance project deliverables; review materials to ensure consistency and quality.
  • Propose, draft, and review publications relevant to CHEER project activities.
  • Develop and manage the implementation of the project performance management plan and key performance indicators, including preparing regular performance reports and progress reports as needed for funders and other stakeholders.
  • Organize CHEER Team and CHEER Committee teleconferences and meetings by developing agendas, minutes and meeting materials, and following up on commitments.
  • Organize and engage in CHEER networking activities and events, including conferences and outreach activities; ensure there is on-going and effective communication within the broader CHEER research team and with the research sites; liaise with research partners.
  • Coordinate the development of CHEER communication activities including website development and maintenance, newsletters and social media and email campaigns; assist with developing CHEER presentations and publications.
  • Identify, recommend, and draft applications for funding opportunities that are within the scope of the CHEER project’s activities.
  • Undertake other duties as delegated in support of the successful conduct of the CHEER Project.

 

REQUIRED QUALIFICATIONS:

  • A Masters or PhD degree in a relevant field, or a health professional with equivalent research experience.
  • Minimum of five (5) years relevant experience in high-level coordination of complex research projects. Preference will be given to applicants with experiences related to research ethics review, and/or preparing applications for research ethics review.
  • Demonstrated experience and expertise/proficiency with communication processes and social media tools.
  • Able to travel to participate in meetings, as required.
  • Bilingualism considered an asset.
  • Consideration may be given to an equivalent combination of education and experience.

 

SPECIAL SKILLS:

  • Promotes equity, diversity and inclusion within the workplace.
  • Effective independent decision making and judgement abilities in addressing complex and sensitive issues regarding research plans.
  • Ability to manage and prioritize multiple competing tasks.
  • Excellent organizational skills and attention to detail with a high degree of accuracy.
  • Excellent project management skills and ability to manage multiple priorities.
  • Excellent time management and problem- solving skills with strong analytical capabilities.
  • Ability to conduct research and gather and synthesize information from multiple sources.
  • Strong verbal and written communication skills, including a proven capacity to present information clearly and communicate effectively with healthcare practitioners and researchers.
  • Proven ability to create and implement projects with minimal supervision and guidance.
  • Ability to work collaboratively with a range of research stakeholders.
  • Strong computer skills including word processing, spreadsheets, PowerPoint and data analysis.
  • Proven ability to work effectively as a team member, including when team members are located in diverse geographic locations.

 

DECISION MAKING:

  • Ability to work independently and be self-directed within guidelines provided by the CHEER leadership team.
  • Independently manage day-to-day priorities in support of achieving overall project goals.
  • Assess best alternatives or a range of solutions to a given problem; identify potential risks and benefits of each.
  • Decide how new information will change the course of a project or event and recommend appropriate responses to ensure highest possibility for success.
  • Determine best solution to administrative problems within guidelines and determine if policy or procedure should be modified. Decide on how to best implement changes if necessary.
  • Effectively answer questions regarding CHEER project issues or redirect inquiries if necessary.
  • Determine the best way to analyze and present data in order to meet the needs of the research project.
  • Resolve problems as they arise and determine when to report on these actions to theCHEER leadership team
  • Oversee, delegate, and review the work of members of teams or working groups thatthe incumbent leads
  • Evaluates employee performance and recommends on appropriate training orcoaching to address lack of proficiency in carrying out responsibilities, or remedialaction for staff disciplinary situations.

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.