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Clinical Research Associate
2 months ago
Are you an experienced regional CRA looking to join a global leader in clinical research with a reputable sponsor-aligned program? This is an excellent opportunity to apply with ICON PLC.
The studies are intriguing, and the travel is very regional, with a great work-life balance. As a Clinical Research Associate, you will be working on multiple trials within Oncology, focusing on quality of life. You will have the opportunity to demonstrate leadership through involvement in specific initiatives and mentor junior team members.
Key Responsibilities:- Work on multiple trials within Oncology, focusing on quality of life
- Quality of life focus with regional travel
- Demonstrate leadership through involvement in specific initiatives
- Mentor junior team members
- Act as a lead SME, training other SMs on study
- Develop site start-up documents for studies, including SIV agendas
- Provide SM "voice" when reviewing study documents
- Represent LTMs or SMs on SMTs/meetings
- Take over LTM role reports review for sites assigned to other SMs from the same trial
- Support country budget development and/or contract negotiation in liaison with CCS colleagues
- Assist with ASV
- 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.)
- Minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
- Located in Western Canada
- Minimum of 23 years' experience in monitoring pharmaceutical industry clinical trials
- Oncology experience required
- Knowledge of several therapeutic areas, including oncology, is an asset
- 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 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
- 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 sponsorship for employment visa status
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 benefits, including various annual leave entitlements, health insurance offerings, competitive retirement planning, and a global Employee Assistance Program.
We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates.
At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We're committed to providing a workplace free of discrimination and harassment.
