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Clinical Research Associate I/II
2 months ago
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.)
What do you need to have?
- Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
- Must be located in Western Canada
- Have a minimum of 1-3 years’ experience in monitoring pharmaceutical industry clinical trials
- Oncology experience required
- Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc
- 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 Canada, and should not require, now or in the future, sponsorship for employment visa status.
