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About the Role

The Senior Clinical Research Associate is responsible for site management, monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution. This role manages investigator site relationships to ensure effective delivery of clinical trials, safeguards site quality and compliance, and maintains engagement and satisfaction of site staff.

Responsibilities

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation through to database lock.
• Serve as the primary point of contact for assigned investigator sites during study conduct.
• Interface with the study team as needed, facilitating information flow between study team members, vendors, and assigned investigator sites.
• Perform investigator site development, coaching, and training of site personnel to ensure ongoing compliance with protocol and patient safeguarding.
• Provide protocol training to, and address protocol-related questions from, investigator site staff.
• Attend investigator meetings when required.
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.
• Define and support recruitment initiatives at the site level.
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities.
• Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit.
• Submit all required reports, documentation, updates, and tracking within required timeframes.
• Identify and resolve investigator site issues within required timeframes.
• Develop corrective and preventative actions with investigator and site personnel to close open issues.
• Resolve data queries within required timelines.
• Prepare investigator site close-out plan and conduct close-out activities within required timelines.
• Ensure adequate oversight of the investigational product at the investigator site.
• Support database release as needed.
• Undertake the responsibilities of an unblinded monitor where required.
• Maintain a thorough understanding of the product, protocol, and therapy area.
• Interact with investigator site healthcare professionals in a manner that enhances Pfizer’s credibility and scientific leadership.
• Support the study clinician in ensuring patient safety and eligibility and providing clinical guidance to investigators.
• Drive Quality Event remediation when applicable.
• Serve as a point of contact for audit conduct and drive Audit Observation CAPA development and checks when applicable.
• Mentor/train Clinical Research Associates as assigned.
• Serve as an SME for CRA-related processes.
• Participate in regional or local working groups/process improvement initiatives.
• Perform activities under guidance of a Site Care Partner prior to site activation.
• Conduct co-monitoring activities as requested.

Requirements

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background, or equivalent.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.
• Minimum 3 years of relevant experience in clinical research site monitoring (preferably 2 years in Oncology).
• Global clinical trial experience.
• Must be fluent in English and in the native language(s) of the country they will work in.
• Advanced knowledge of clinical research and development processes and ability to gain command of process details.
• Demonstrated knowledge of global and local regulatory requirements.
• Advanced understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.).
• Advanced knowledge in disease and technical areas pertaining to clinical studies.
• Demonstrated ability to support sponsor regulatory interactions/inspections.
• Demonstrated knowledge of the processes around protocol design and feasibility assessment.
• Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery.
• Proven ability to work in a matrix team environment with the ability to influence, drive/lead, and work through others for successful delivery of clinical trials.
• Proven ability to evaluate, interpret, and present complex issues and data to support risk management and mitigation.
• Effective verbal and written communication skills.
• Significant travel (60-80%) within the area is required.
• May require some international travel and some weekend travel.
• Valid driver’s license and passport required.

Skills

• Clinical Trial Monitoring
• Site Management
• Patient Safety
• Good Clinical Practices (GCP)
• Protocol Compliance
• Enrollment Support
• AE/SAE Monitoring
• Data Query Resolution
• Investigational Product Oversight
• Risk Management
• Communication Skills
• Mentoring
• Process Improvement

Location

• Remote

Work Type

• Full-time

Experience Level

• Senior
• Minimum 3 years relevant experience
• 2 years in Oncology preferred

Education Level

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

About the Company

• Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives.
• We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Equal Opportunity

• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
• To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.