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Oncology Clinical Research Associate II

1 month ago

Canada ICON Strategic Solutions Full time

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
  • 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 Canada
  • Will work on US remote monitoring only
  • Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
  • Have a minimum of 1-3 years' experience monitoring Oncology trials
  • Knowledge of several therapeutic areas
  • 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.
  • 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