Clinical Research Operations Officer
at
University of Ottawa Heart Institute
Ottawa, ON, Canada
-
Full Time
Start Date
Immediate
Expiry Date
17 Sep, 25
Salary
55000.0
Posted On
28 Aug, 25
Experience
3 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Workshops, Clinical Research, Medical Terminology
Industry
Pharmaceuticals
Description
Responsibilities
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.).
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.
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