The Ottawa Heart Institute Research Corporation (OHIRC) is the research arm of the University of Ottawa Heart Institute. The Office of Clinical Research and Compliance is responsible for support of the clinical research enterprise. We are currently expanding our team to enhance support and oversight around study conduct, including risk-based study monitoring and study start-up activities. This position requires extensive experience in the clinical research environment.
Responsibilities
The Clinical Research Facilitator will be responsible for activities primarily related to study conduct, including but not limited to:
- Risk-based monitoring for investigator-initiated studies
- Championing study start-up support for investigator-initiated studies (e.g., hosting study start-up meetings as needed, providing guidance on monitoring plans and study-level quality management system, recommending resources, etc.)
- Developing relationships with clinical research staff and Investigators to provide guidance and support
- Creating a reporting dashboard
- Providing onboarding support to new clinical research staff and Investigators
- Delivering education to clinical research staff, creating and developing templates and tools, and providing guidance on clinical research processes and compliance
- Oversight of clinical trials registration and maintenance in Clinicaltrials.gov and user management
- Participating in the orientation and training of new clinical research staff and Investigators
- Assisting study teams with regulatory Trial Master File (TMF) setup
- Serving as a member of the Clinical Research Standard Operating Procedures (SOPs) Committee
- Attending meetings including monthly clinical research staff meetings, team meetings, Clinical Research Brainstorming Sessions, and meet-and-greets with new Investigators
- Conducting for-cause study audits as needed
- Providing support for Health Canada inspections and external audits
Basic requirements
- Bachelor’s degree in a health science related field or equivalent
- Minimum 5 years of experience in clinical trial practices and protocols in an academic health care environment (preferred) or industry
- Experience monitoring complex clinical trials or similar experience or training
- Experience managing international investigator-initiated research studies
- Extensive understanding of PHIPA, TCPS2, ICH-GCP Guidelines, and Health Canada regulations, with evidence of recent training
- Strong computer skills, including experience with Microsoft Outlook, Word, Excel, and PowerPoint
Preferred qualifications
- Clinical Research Certification (SOCRA or ACRP) or degree or certificate in clinical research
- Experience using electronic data capture systems (i.e., REDCap, Dacima)
- Knowledge of US FDA and other international regulations
- Knowledge of GDPR requirements
- Experience with the EPIC electronic health record system
Personal suitability
- Highly motivated with the ability to work independently, managing competing priorities effectively to meet deadlines and expectations while remaining flexible and adapting to ever-changing demands
- Meticulous attention to detail, strong organizational and planning skills
- “Customer” service oriented (i.e., 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
- Ability to provide constructive criticism in a professional and educational manner
- Strong conflict resolution skills
- Ability to manage confidential information
To apply
Please send your cover letter and CV to jobpostings@ottawaheart.ca.
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 two doses of COVID-19 vaccine.