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
- Senior Clinical Scientist leading oncology clinical trials for ICON’s sponsor-dedicated research programs. Providing medical monitoring, scientific oversight, and protocol execution across US and Canadian locations.
Responsibilities
- Lead or support studies depending on size and complexity
- Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders
- Lead trial design and endpoint development in collaboration with the Clinical Director
- Lead the Medical Monitoring team, including Medical Monitoring Plan development and SAE report review
- Set up and support SAC, DMC, and adjudication committees
- Collaborate on protocols and amendments and participate in governance committee review
- Author protocol clarification letters and contribute to study-specific documents
- Review and update informed consent materials
- Provide scientific input to study management for data management activities
- Monitor data issues, central laboratory reports, and external safety data
- Prepare scientific slides and present protocol information at Investigator Meetings
- Serve as scientific lead on the Clinical Trial Team
- Review specifications and initiate allocation and randomization requests
- Coordinate laboratory, biospecimen, and imaging specifications
- Co-author newsletters and participate in database lock activities
- Collaboratively plan CSRs and CTDs/WMAs with medical writing
- Support publications and presentations
- Reconcile and review protocol deviation classifications and prepare protocol deviation lists for CSRs
- Collaborate with medical writing on trial results communications
- Provide scientific assessments for Operational Reviews
- Support study management and medical writing activities to achieve Clinical Trial Team deliverables
- Provide clinical specifications for external vendor interactions
- Mentor other Clinical Scientists as needed
Requirements
- BS/BA in Life Sciences with 7+ yrs clinical research experience
- MS/PhD in Life Sciences with 5+ years clinical research experience
- If no degree in Life Sciences, significant experience in clinical development (>11 years)
- Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required
- Medical monitoring experience required
- Oncology experience required
- Excellent Excel and PP skills required
- Excellent written and oral communication skills
- Ability to travel up to 15% (might include international travel)
- Legally authorized to work in Canada or the US
- Must not require, now or in the future, sponsorship for employment visa status
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
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