Clinical Research Associate II conducting onsite monitoring and regulatory support for PSI, a contract research organization. Managing sites, CRF review, queries, and study progress across clinical trials.
About the role
- Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organization. Ensuring protocol, ICH-GCP, and regulatory compliance across investigative sites.
Responsibilities
- Monitor the progress of clinical studies at investigative sites or remotely
- Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol
- Follow standard operating procedures (SOPs), ICH-GCP, and applicable regulatory requirements
- Support clinical research for pharmaceutical, biotechnology, medical device, government, and public health organizations
- Travel up to 70%
Requirements
- Bachelor's degree, or its international equivalent in a scientific or health-related field, or an equivalent combination of education and clinical research experience
- 1+ years of clinical monitoring experience or equivalent combination of education and experience for the level 2 role
- 3+ years of clinical monitoring experience for a level 3 role
- Oncology monitoring experience preferred
- Ability to travel 70%
- Knowledge of ICH and local regulatory authority regulations regarding drug trials
- Legally authorized to work in the United States or Canada
- Must not require, now or in the future, sponsorship for employment visa status
- Bilingual English/French required
- Employment contingent upon having the legal right to work in the country where the role is based
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
- Comprehensive and competitive total reward package
- Supportive policies and wellbeing initiatives
- Continuous learning culture and professional development opportunities
- Equal opportunity and inclusive workplace
- Reasonable accommodation during the recruitment process
- Benefits may vary depending on role and location
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