Senior Clinical Research Associate II

🔥 0 minutes ago

🇨🇦 Canada – Remote

💵 $92.1k - $153.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• 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