QUALIFICATIONS:

§ Bachelor’s degree in a research or health-related field (Master’s preferred); 3+ years experience in clinical
research, preferably in oncology and/or pediatric trials.
§ Experience with clinical trial agreements, study start-up, regulatory requirements, protocol development, and
Health Canada/REB submissions.
§ Knowledge of Canadian (Division 5, ICH GCP) and US (NIH, FDA) regulations
§ 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
To apply: Please email your resume directly to Kathy Brodeur-Robb at kathy.brodeur-robb@c17.c

§ Negotiate and manage contracts and agreements with clinical trial sponsors, research institutions, and other
stakeholders, ensuring alignment with regulatory and ethical standards in Canada.
§ Collaborate with legal, regulatory, and finance teams to ensure contractual obligations are met and budgets are
aligned with trial protocols.
§ Support regulatory compliance, ensuring C17, sponsors and sites meet ICH-GCP and Division 5 requirements.
§ Develop, review, and implement policies related to clinical trial operations and regulatory compliance.
§ Support site start-up activities including feasibility assessments, budget development, contract negotiations, and
identifying Canadian study requirements for international/Canadian trials.
§ Lead and support advocacy initiatives in collaboration with advocacy groups aimed at improving access to
investigational drugs and streamlining clinical trial processes across provinces.
§ Understand the complex and diverse environment of clinical trials, drug development, HTA and drug
funding/access and develop pragmatic and creative approaches to problem solving issues.
§ In addition to primary responsibilities above, the Research Project Manager may provide support in the
following areas, depending on their education and experience: monitoring compliance of Canadian sites with
Health Canada regulations for multicentre clinical trials, national and provincial REB initiatives and applications,
precision medicine programs, managing single patient studies, operationalizing remote access and decentralized
clinical trial options, research grant management and reporting, assisting with C17 operations and office
responsibilities.