Quality Assurance Lead
2 weeks ago
The Ottawa Hospital Research Institute is the research arm of The Ottawa Hospital – one of Canada’s largest learning and research hospitals. We are proudly affiliated with the University of Ottawa and supported by The Ottawa Hospital Foundation. With more than 2200 scientists, clinician investigators, trainees and staff, and total revenues of more than $120 million, we are one of the foremost Canadian hospital-based research institutes. Our research spans more than a hundred different diseases, conditions, and specialties with an overall focus on translating discoveries and knowledge into better health.
Job Description
The Ottawa Blood Disease Centre at OHRI is seeking an experienced Clinical Research Coordinator to join the Hematology Research Program as the new Quality Assurance (QA) Lead. The QA Lead will play a pivotal role in ensuring the quality, regulatory compliance, and integrity of research activities within the Hematology Research Program. This position will be responsible for developing and maintaining a robust QA program, implementing standardized procedures, providing training and support to staff and investigators, and overseeing risk management and regulatory compliance efforts. The QA Lead will collaborate closely with the Senior Research Program Manager, research staff, investigators, and OHRI's Research Administration team to align with institutional and Health Canada protocols and standards. The QA Lead will be instrumental in promoting a culture of quality and continuous improvement within the Hematology Research Program.
Basic Requirements (Education/Experience):
•Bachelor's degree in a health science related field or equivalent.
•Minimum of 5 years of experience in clinical research with a comprehensive understanding of the clinical research process and unique requirements of both investigator-initiated and industry-sponsored trials.
•Strong understanding of regulatory requirements governing clinical research (e.g., ICH-GCP, FDA regulations, Health Canada guidelines).
•Excellent communication and interpersonal skills, with the ability to effectively mentor and train staff at all levels.
•Proven ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.
•Requires keen attention to detail, strong organizational skills, and a commitment to maintaining rigorous standards of quality and integrity in clinical research.
•Experience working with multidisciplinary teams and fostering a culture of collaboration and accountability.
•Knowledge of a variety of computer software program including word processing, spreadsheet, and database applications.
Preferred Qualifications:
•Experience developing and implementing quality assurance programs or initiatives within a clinical research setting.
•Certification in quality assurance or clinical research (e.g., ACRP, SoCRA) preferred.
•Bilingual in French is a strong asset.
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