Senior Clinical Research Associate I

🔥 0 minutes ago

🇨🇦 Canada – Remote

💵 $73.7k - $122.8k / 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 clinical trial investigator sites • Ensure patient safety and quality study execution in accordance with applicable laws, Good Clinical Practice (GCP) and Pfizer standards • Manage investigator site relationships to support enrollment, database release, site quality, GCP compliance and stakeholder engagement • Manage operational clinical trial activities from site initiation through database lock • Serve as the primary contact for assigned investigator sites and escalate issues to the Site Care Partner • Facilitate information flow among study team members, vendors and investigator sites • Train and coach site personnel on protocols, operational risks and clinical trial risks • Attend investigator meetings virtually or in person when required • Support enrollment and recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and site closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit trial documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management updates and study metrics • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct site closeout activities • Oversee investigational product receipt, handling, accountability, storage and destruction • Support database release and perform unblinded monitor responsibilities when required • Maintain product, protocol and therapeutic-area knowledge • Support patient safety, eligibility and clinical guidance • Drive quality-event remediation and the development and review of CAPAs for audit observations • Mentor and train Clinical Research Associates • Serve as a subject-matter expert for CRA-related processes • Participate in working groups and process-improvement initiatives • Support feasibility assessments, site selection, pretrial assessments, site activation checklists, informed consent document finalization and site initiation visits • Conduct co-monitoring activities as requested

🎯 Requirements

• Bachelor's degree in life sciences or a professional degree in life sciences, such as nursing, pharmacy, medicine or an equivalent field • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and applicable local-country regulations • Minimum of 3 years of relevant experience in clinical research site monitoring • Preferably 2 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 of employment • Advanced spoken and written English proficiency • Advanced knowledge of clinical research and development processes • Knowledge of global and local regulatory requirements • Understanding of clinical research operational elements, including monitoring, data acquisition and cleaning, and reporting • Knowledge of diseases, technical areas, investigational products and associated 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 • Effective verbal and written communication skills • Significant travel availability (60–80%) within the assigned area, with possible international and weekend travel • Valid driver's license and passport required

🏖️ Benefits

• Commitment to diversity and inclusion • Equitable workplace • Accessible candidate experience and recruitment accommodations • International and weekend travel opportunities as part of the role