Associé de recherche clinique II // Senior Clinical Research Associate II

Posting closes September 4, 2026. Regular, full-time position.

About the role

The Senior Clinical Research Associate II ensures the management, monitoring, and closeout of assigned clinical trial investigator sites to guarantee patient safety and high-quality study execution in compliance with applicable laws, Good Clinical Practices (GCP), and Pfizer standards. This role involves managing investigator site relationships to ensure effective trial delivery (e.g., subject enrollment, data dissemination), maintaining site quality (e.g., patient safety, GCP compliance), and fostering investigator and site staff engagement and satisfaction. The role also includes resolving protocol-related issues at assigned sites and collaborating with the Site Care Partner and study team members for site setup, execution, and closeout.

Responsibilities

• Manage and monitor assigned investigator sites to ensure clinical trials proceed according to the study monitoring plan, applicable laws, GCP, and Pfizer standards, meeting quality, timeline, and objective expectations.
• Oversee operational aspects of clinical trial activities at assigned sites, from site initiation to database lock, ensuring timelines and quality expectations are met.
• Serve as the primary point of contact for assigned investigator sites during the study.
• Collaborate with Site Care Partners to address site execution quality issues and facilitate information exchange among team members, vendors, and sites.
• Provide training, mentorship, and guidance to site staff to ensure protocol compliance and patient safety; address operational and clinical trial risks as needed.
• Attend investigator meetings (virtually or in-person) as required.
• Support subject recruitment and address investigator concerns related to study startup and enrollment.
• Collaborate with Site Care Partners and the study team to define and support site recruitment initiatives.
• Conduct on-site, remote, and electronic monitoring to ensure study startup, regular monitoring, and closeout activities align with the monitoring plan and standard operating procedures (SOPs), incorporating emerging technologies and issues.
• Monitor adverse events (AEs) and serious adverse events (SAEs) at sites, collaborate with drug safety team members, and follow up with investigators to resolve SAE report issues requiring action.
• Prepare and submit all required reports, documents, updates, and follow-ups on schedule, including study master file documentation, site reports, visit follow-up letters, protocol deviations, subject recruitment, clinical supply management, study progress, and metrics.
• Identify and resolve site issues within established timelines; agree on corrective and preventive actions with investigators and site staff.
• Address data queries on schedule, prepare the site closeout plan, and conduct closeout visits as required.
• Ensure proper monitoring of investigational products at sites, including receipt, handling, accountability, storage, and destruction.
• Support data dissemination as needed.
• Assume responsibilities of an unblinded Study Monitor when necessary.
• Maintain in-depth knowledge of products, protocols, and therapeutic areas to facilitate appropriate discussions with investigators and site staff.
• Interact with site healthcare professionals to enhance Pfizer’s scientific credibility and leadership, supporting clinical development goals.
• Assist the study clinician in ensuring patient safety and eligibility, and provide clinical guidance to investigators.
• Implement corrective actions for quality-related events as needed.
• Serve as a resource for audit conduct and lead the development and verification of corrective and preventive actions from audit findings.
• Mentor and train assigned Clinical Research Associates and Junior Clinical Research Associates.
• Act as a subject matter expert for CRA-related processes.
• Participate in or lead global, regional, or local process improvement initiatives or working groups.
• Serve as the Site Care Partner for small projects or under supervision for larger projects, including site feasibility, selection, pre-trial assessments (PTAs), site activation checklist coordination, informed consent form (ICF) development, and site initiation visits (SIVs). Manage issues that may delay site activation.
• Conduct co-monitoring activities.

Requirements

• Bachelor’s degree in life sciences or a professional degree in life sciences (e.g., nursing, pharmacy, medicine, or equivalent).
• Extensive knowledge of clinical trial methodologies, International Council for Harmonisation Good Clinical Practice (ICH-GCP), FDA regulations, and local regulations.
• Minimum of five years of relevant clinical site monitoring experience, with preference for three years in oncology.
• Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases is desired.
• Experience in global clinical trials.
• Fluency in English and the primary language(s) of the country of employment.
• Advanced proficiency in English (oral and written) is required for effective collaboration with colleagues and partners in Canada and internationally.

Skills

• Advanced knowledge of clinical study methods and clinical development, with the ability to master process details.
• Established understanding of local and global regulatory requirements.
• Strong grasp of key operational elements of clinical research (e.g., monitoring, data acquisition and management, reporting).
• In-depth knowledge of diseases and technical areas related to clinical studies, including company direction, investigational products, and associated development plans.
• Proven ability to engage with sponsor regulatory teams and participate in regulatory interactions and inspections.
• Strong understanding of protocol design and feasibility assessment processes.
• Deep understanding of regional/country medical culture and practices and their impact on clinical study execution.
• Demonstrated ability to work in a matrix team environment, influence, motivate, and lead others to successfully implement clinical studies.
• Superior ability to assess, interpret, and present complex issues and data to support risk management and mitigation.
• Excellent oral and written communication skills with colleagues and stakeholders inside and outside the company.
• Proven ability to motivate and mobilize the monitoring community through leadership and mentorship.
• Travel required (60–80% of the time) within the region, with potential for international and weekend travel.
• Valid passport and driver’s license.

Pay

Annual base salary for this position ranges from $92,100 to $153,500 CAD (applicable only in Canada).