Clinical Research Associate

3 months ago

Toronto, Canada ICON 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
- 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.

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

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