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Senior Clinical Research Associate II
PfizerSenior Clinical Research Associate monitoring Pfizer clinical trials across remote Canadian investigator sites. Ensuring patient safety, regulatory compliance, recruitment and study closeout.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations, with a strong ability to manage investigator sites and ensure compliance throughout the clinical trial process. Proven experience in mentoring and training clinical research associates while effectively collaborating with cross-functional teams.
Highest-signal resume keywords
Clinical Trial MonitoringGood Clinical Practice (GCP)Oncology ExperienceRegulatory ComplianceSite Management
ATS Keywords
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Hard Skills
Clinical Trial MethodologiesData Acquisition and CleaningProtocol DesignAdverse Event MonitoringCAPA DevelopmentSite Close-Out ActivitiesInvestigational Product ManagementPatient Enrollment SupportRisk ManagementDatabase Lock Management
Soft Skills
Verbal CommunicationWritten CommunicationLeadershipMentorshipCollaboration
Industry Keywords
Clinical ResearchFDA RegulationsICH GuidelinesOncologyVaccinesInternal MedicineInfectious DiseasesGlobal Clinical TrialsSite Care PartnerClinical Development Processes
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Commitment to diversity and inclusion
- Equitable and accessible workplace
- Accommodations available during the recruitment process
- Candidate AI-use guidelines