Oncology Clinical Research Associate II - Ontario

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What will you be doing? Works on multiple trials within Oncology Quality of life focus wtih Regional Travel Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team Acts as Lead SM-training other SMs on study Develops site start up documents for studies including SIV agenda Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines) Represents LTMs or SMs on SMTs/meetings Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial Supports country budget development and/or contract negotiation in liaison with CCS colleagues Assists with ASV Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces – Primary/Other: Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) Qualifications Needed: Based in the Toronto, Ontario area (near a major airport) Have a minimum of a B.Sc ., R.N., or equivalent degree, preferably in Biological Sciences Have a minimum of 2 years’ experience in monitoring pharmaceutical industry clinical trials Oncology experience required Knowledge of several therapeutic areas, with oncology an asset but not a requirement. Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. Need to travel up to 50% To qualify, applicants must be legally authorized to work in the Canada, and should not require, now or in the future, sponsorship for employment visa status.

Location: Ontario, CA

Posted Date: 11/6/2024