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SalaryJob Posting
Research Manager, C17 Council, Pediatric Hematology/Oncology
Status: 1.0 FTE – Full time
City/Town: Remote work available, office based in Edmonton
Closing Date:
Position Starts: 1 April 2024 or when available
Hours of Work: Days, Standard 8 hours / day Monday – Friday, 8:00 am – 4:00 pm – flexible based on location/personal
preference, occasional travel/weekend days
Salary: Commensurate with experience
C17 Council is a network that links the 16 Hematology/Oncology and Bone Marrow Transplant programs across Canada. It
includes work in research, regulatory compliance, education, human resources and advocacy. Our work includes
international collaborations, working with researchers, REBs, institutions, cooperative groups, pharmaceutical
companies and patient and family advocates. Our office has moved to a fully remote work from home model, with some
office support in Edmonton, Alberta.
Responsibilities/Duties:
The Research Manager, Regulatory Affairs will report to the C17 Executive Director
Work with the C17 office, centres across Canada and the executive to fulfill the research, regulatory and
education mandate of C17
The primary focus of this position will be regulatory management of all academic clinical trials overseen by C17
group multicentre clinical trials. This includes:
- Preparation of submissions to Health Canada (CTA, CTA-A, CTA-N, RFIs, safety reporting) for academic
- Maintenance of study files for 100+ studies
- Liaise between institutions, investigators, research staff, sponsors, companies, and Health Canada for study
- Interaction with sites to ensure compliance with the regulations and protocol
- Ensure C17 is up to date on new regulations and guidances and implementing new processes to reflect
- Responsible for maintaining, creating and revising Regulatory SOPs
- Responsible for oversight of the monitoring programs for all studies managed by C17, including reviewing
worksheets and reports prior to release to external stakeholders, review/revision of monitoring plans bi-
annually
- Preparation of presentations, regulatory office stats for dissemination to stakeholders
- Preparation of study documents for distribution to sites
- Assist with C17 operations and office responsibilities
Qualifications:
Minimum of a Bachelor's degree in a research or health-related field; 5+ years clinical research experience;
exceptions can be made if experience or track record indicates capability and suitability.
Experience in oncology and/or hematology preferred
Knowledge of Canadian (Division 5) regulations, ICH GCP and US (NIH, FDA) regulations
Experience with monitoring and regulatory oversight
Familiarity with computer software, databases and website development
Excellent organizational, communication, problem-solving and interpersonal skills, high degree of accuracy and
attention to detail
Able to take initiative and work in a team environment or independently; capacity to be flexible, work well
under pressure and able to meet deadlines
Able to work efficiently, in a professional, confidential and ethical manner in accordance with industry
policies/procedures
Knowledge of French (particularly written) would be asset
Canadian citizenship or permanent residency and living in Canada required
To apply: Please email your resume and cover letter directly to Kathy Brodeur-Robb at
kathy.brodeur-robb@c17.ca
