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.
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.
- 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.
- 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: email@example.com
Deadline for submission of applications is December 8, 2023.
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.
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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.
- 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.
- 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.
- 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.
- 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 firstname.lastname@example.org.
We invite you to share our salary awards exciting opportunity with your networks! The IMPaCT salary awards offer a 1-year immersive learning experience with dedicated mentors and deliverables. This program equips participants with the skills and network needed to lead and communicate about clinical trials involving pregnant individuals and children, from neonates to adolescents. For the 2023 trainees the application is due on November 1, 2023.
There are 15 awards available, including 3 Ph.D. awards ($35,000), 3 Postdoctoral awards ($50,000), and 9 Early Career Researcher (ECR) awards ($70,000) per year. Notably, there are dedicated awards for Black and Indigenous scholars (2 awards). Eligibility criteria include being affiliated with a Canadian Academic Institution or child health research institute, being at the doctoral, postdoctoral, or Early Career Researcher stage, and holding Canadian citizenship or permanent residency. Candidates must have an interest in designing perinatal and child health clinical trials, with clinical trial questions in the idea/protocol development phase and a focus on pregnant individuals or children up to 18 years old, spanning various intervention types and trial phases. Adaptive and innovative approaches are encouraged, and any questions about eligibility can be directed to Linda (email@example.com). Please help us spread the word about this valuable opportunity! We also attached our promotional flyer to this email for you to share.
The Canadian Institutes of Health Research (CIHR) is committed to strengthening the clinical trials ecosystem to improve health care and health outcomes for all Canadians. CIHR is now looking to build a long-term strategy to support Canada’s clinical trials ecosystem. In the fall of 2022, CIHR launched Building the future of clinical trials, an online consultation with the research community, partners, and stakeholders involved in clinical trials. Participants were asked questions about CIHR’s role in funding clinical trials and in developing related policies and programs. Their discussions and preliminary recommendations will inform our ongoing conversations in order to shape the development of a long-term clinical trials strategy.
CIHR received a total of 44 responses from researchers, patient and citizen groups, research and health networks, government departments, and several organizations between September 28, 2022, and December 1, 2022. These 44 responses represent the collated comments from over 140 individuals, representing over 100 organizations or groups of stakeholders.
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