Senior Clinical Scientist leading infectious - disease and HIV clinical trial science at ICON, a global healthcare intelligence and clinical research organisation. Driving protocols, medical monitoring, data review, and regulatory deliverables.
About the role
- Senior Clinical Research Associate monitoring Pfizer clinical trials across remote Canadian investigator sites. Ensuring patient safety, regulatory compliance, recruitment and study closeout.
Responsibilities
- Manage, monitor and close out assigned investigator sites for clinical trials
- Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practice (GCP) and Pfizer standards
- Manage operational aspects from site initiation through database lock
- Serve as the primary point of contact for assigned investigator sites
- Collaborate with the study team, Site Care Partner, vendors and investigator sites
- Coach and train site personnel on protocols, operational risks and clinical trial risks
- Attend investigator meetings as required
- Support patient enrollment and recruitment initiatives
- Conduct onsite and remote/electronic monitoring during site initiation, routine monitoring and site closure
- Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
- Submit required reports, Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply information, study progress updates and metrics
- Identify and resolve site issues and develop corrective and preventive actions
- Resolve data queries and conduct site close-out activities
- Oversee investigational product receipt, handling, accountability, storage and destruction
- Support database release and perform unblinded monitor responsibilities when required
- Drive quality event remediation and develop and review CAPAs for audit observations
- Mentor and train Clinical Research Associates and Senior Clinical Research Associates I
- Serve as a subject matter expert for CRA-related processes
- Participate in or lead global, regional or local working groups and process improvement initiatives
- Perform Site Care Partner duties for small projects or under guidance for larger projects
- Conduct co-monitoring activities
Requirements
- Bachelor’s degree in life sciences or a professional degree in a life sciences field, such as nursing, pharmacy or medicine, or equivalent qualifications
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA regulations and local country regulations
- Minimum of 5 years of relevant experience in clinical research site monitoring
- Preferably 3 years of experience in Oncology
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- Experience with global clinical trials
- Fluency in English and the native language(s) of the country in which the individual will work
- Bilingualism in French and English; advanced spoken and written English required
- Superior knowledge of clinical research and development processes
- Knowledge of global and local regulatory requirements
- Understanding of clinical research operations, including monitoring, data acquisition and cleaning, and reporting
- Knowledge of diseases, technical areas, investigational products and development plans
- Ability to support sponsor regulatory interactions and inspections
- Knowledge of protocol design and feasibility assessment
- Understanding of regional and country-specific culture and medical practice
- Ability to work in a matrix team environment and influence, drive or lead initiatives through others
- Ability to evaluate, interpret and present complex issues and data for risk management and mitigation
- Superior verbal and written communication skills
- Ability to motivate and align the monitoring community through leadership and mentorship
- Significant travel (60–80%) within the cluster; international and weekend travel may be required
- Valid passport and driver’s license
Benefits
- Commitment to diversity and inclusion
- Equitable and accessible workplace
- Accommodations available during the recruitment process
- Candidate AI-use guidelines
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