Term
Two years.
Introduction
The Ottawa Heart Institute Research Corporation is the research arm of the University of Ottawa Heart Institute (collectively, the “Institute”). The Office of Clinical Research and Compliance is responsible for supporting and enabling clinical research activities while promoting compliance with regulatory requirements. We are expanding our team to enhance support for our Office, clinical research teams and clinical research activities at the Institute.
Responsibilities
The Clinical Research Operations Officer will be responsible for tasks including but not limited to:
- Drafting study management documents in collaboration with study team (e.g. Monitoring Plan, Data Management Plan, Trial Master File Plan, etc.).
- Completing departmental impact forms for studies in coordination with the study team (e.g., imaging, EORLA, etc.).
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Contributing to day-to-day activities within the Office of Clinical Research and Compliance, such as:
- Assisting the Research Ethics Facilitator with initial Research Ethics Board (REB) applications.
- Gathering quality metrics for reporting in collaboration with the Manager.
- Conducting reviews of essential study documents alongside the Clinical Research Facilitators.
- Contributing to large-scale projects led by the Research Integrity and Compliance Officer.
- Documenting key discussions and managing follow-up action items from Office meetings.
- Planning, organizing and leading staff engagement activities such as weekly updates, staff meetings, the annual workshop, team retreats, and other special meetings and education sessions.
- Managing central email account by responding to questions/queries from staff and external parties and directing them to appropriate resources.
- Supporting and organizing onboarding activities for new clinical research staff and investigators (e.g., sending welcome emails, scheduling meet and greets, providing instructions on required training, essential document collection, etc.).
- Managing dedicated clinical research infrastructure such as clinic rooms, supplies and maintenance of common equipment, and internal and external clinical research web content.
- Supporting and managing users of the centralized electronic binder platform (i.e. Florence), including maintenance of the central repository.
- Reconciling office account charges and submitting purchase orders and purchase requests to the Finance Department.
- Collaborating and liaising with other groups in Research Administration, Research Ethics Board (REB), Core Facilities, and external sources to research and develop solutions to clinical research related queries.
- Performing other duties and providing support as requested.
- College or university degree in a relevant field of science.
- A strong working knowledge of PHIPA, TCPS2, ICH-GCP guidelines, and Health Canada regulations, with evidence of recent training.
- Minimum 3 years of experience conducting and supporting clinical research.
- Experience coordinating and compiling REB applications.
- Demonstrated ability to effectively plan, organize, and coordinate a range of events, including team meetings, workshops, and special sessions.
- Advanced working knowledge of Office 365 and the ability to efficiently navigate and learn new electronic platforms.
- Clinical Research Certification (SOCRA or ACRP) or degree or certificate in clinical research.
- Familiar with OHSN-REB and CTO ethics platforms.
- Experience working in a healthcare environment.
- Knowledge of cardiac medical terminology.
- Background in facilitating/supporting both investigator-led and industry-sponsored cardiac related research.
- Highly motivated self-starter with the ability to work independently and effectively organization and manage projects from start to completion.
- Proven ability to manage competing and evolving priorities, while meeting deadlines and expectations and deadlines.
- Meticulous attention to detail.
- Solution-oriented and responsive to requests from the clinical research community.
- Excellent interpersonal skills with the ability to build strong relationships and work collaboratively with the research teams as well as colleagues in Research Administration.
- Excellent written and oral communication skills, including the ability to prepare and deliver presentations to various audiences.
- Flexible and adaptable.
Requirements
- College or university degree in a relevant field of science.
- A strong working knowledge of PHIPA, TCPS2, ICH-GCP guidelines, and Health Canada regulations, with evidence of recent training.
- Minimum 3 years of experience conducting and supporting clinical research.
- Experience coordinating and compiling REB applications.
- Demonstrated ability to effectively plan, organize, and coordinate a range of events, including team meetings, workshops, and special sessions.
- Advanced working knowledge of Office 365 and the ability to efficiently navigate and learn new electronic platforms.
Preferred qualifications
- Clinical Research Certification (SOCRA or ACRP) or degree or certificate in clinical research.
- Familiar with OHSN-REB and CTO ethics platforms.
- Experience working in a healthcare environment.
- Knowledge of cardiac medical terminology.
- Background in facilitating/supporting both investigator-led and industry-sponsored cardiac related research.
Personal suitability
- Highly motivated self-starter with the ability to work independently and effectively organization and manage projects from start to completion.
- Proven ability to manage competing and evolving priorities, while meeting deadlines and expectations and deadlines.
- Meticulous attention to detail.
- Solution-oriented and responsive to requests from the clinical research community.
- Excellent interpersonal skills with the ability to build strong relationships and work collaboratively with the research teams as well as colleagues in Research Administration.
- Excellent written and oral communication skills, including the ability to prepare and deliver presentations to various audiences.
- Flexible and adaptable.
To apply
To apply, please send your cover letter and CV to [email protected].
Applications from Indigenous persons, members of racialized minorities, persons with disabilities, women, members of the LGBTQ+ community, as well as from all qualified candidates with the skills and knowledge to productively engage with equitable, diverse and inclusive communities are strongly encouraged.
According to government policy, all qualified candidates are invited to apply; however, preference will be given to Canadians and permanent residents. When submitting your application, please indicate if you are legally entitled to work in Canada.
The University of Ottawa Heart Institute is committed to ensuring barrier-free selection processes and work environments. Accommodations will be provided in all parts of the hiring process relating to any specialty requirements. Please notify us of any accommodations that you require – any information you provide will be handled respectfully and in complete confidence.
The successful candidate will be required, prior to the start of employment, to complete mandatory organizational training available online, and provide the following: an official piece of photo identification and a satisfactory Criminal Record Check and proof of COVID-19 vaccine.
