Quality Assurance Lead

2 weeks ago


New York, United States Ottawa Hospital Research Institute Full time

Please note, all OHRI applicants must be fully vaccinated in order to be considered for any staff, trainee or volunteer opportunities. Upon hiring, applicants must provide government issued documentation proving they have been fully vaccinated, orpresent supporting documentation of a valid medical contraindication or other reasonable consideration pursuant to the Ontario Human Rights Code.Category: Clinical Research Date Posted: 08-May-2024 End Date: 22-May-2024 ID: 2994Quality Assurance LeadContact/Scientist: Dr David MacdonaldProgram: Clinical EpidemiologyThe Ottawa Hospital Research Institute is the research arm of The Ottawa Hospital one of Canadas 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 DescriptionThe 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.Contract Details:This is a 1-year full-time contract with the possibility of renewal.Salary: min: $ $33.953 - max: $$48.957Comments to Applicant:Please send a complete CV with description of research experience.Contact Info:Name: Amanda PecarskieTitle: Senior Research Program ManagerProgram: HematologyOttawa Hospital Research InstituteEmail: apecarskie@ohri.caThe Ottawa Hospital Research Institute is committed to building and sustaining a welcoming and supportive culture that promotes equity, diversity and inclusion for trainees, researchers, and staff. We are devoted to identifying and removing barriers that limit equitable access to opportunities within our organization. The Ottawa Hospital Research Institute strongly supports initiatives that encourage the participation of all groups, in particular the four groups defined in the Employment Equity Act (women, Indigenous peoples, persons with disabilities and members of visible minorities).We thank all applicants for their interest. However, only those invited for an interview will be contacted. The Ottawa Hospital Research Institute is an equal-opportunity employer. Upon request, accommodations due to a disability are available throughout the selection process.#J-18808-Ljbffr

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