Role Summary
The Senior Clinical Research Associate is responsible for the site management, site monitoring, and closeout of assigned clinical trial investigator sites to ensure patient safety and quality study execution in accordance with applicable regulations, Good Clinical Practice (GCP), and Pfizer standards.
The role is accountable for managing investigator site relationships, ensuring effective delivery of clinical trials, safeguarding site quality and compliance, supporting enrollment and database release activities, and maintaining strong engagement with investigators and site staff. The Senior Clinical Research Associate works closely with Site Care Partners and study team members throughout study start-up, execution, and closeout.
Key Responsibilities
- Manage and monitor assigned investigator sites throughout the clinical trial lifecycle.
- Ensure studies are conducted in accordance with protocol requirements, applicable regulations, GCP, and Pfizer standards.
- Serve as the primary point of contact for assigned investigator sites during study conduct.
- Partner with Site Care Partners and study teams to support site performance and quality delivery.
- Support site activation, patient recruitment, enrollment, and study progress.
- Conduct on-site, remote, and electronic monitoring visits, including site initiation, routine monitoring, and closeout visits.
- Review and follow up on adverse events (AEs) and serious adverse events (SAEs) as required.
- Maintain study documentation, monitoring reports, follow-up letters, protocol deviation records, and Trial Master File documentation.
- Identify site-level issues and implement corrective and preventive action plans when necessary.
- Resolve data queries and support database release activities.
- Ensure appropriate oversight of investigational product management at investigator sites.
- Participate in investigator meetings as required.
- Support audit readiness and quality event remediation activities when applicable.
Additional Responsibilities
- Mentor and train Clinical Research Associates, as assigned.
- Serve as a subject matter expert for CRA-related processes.
- Participate in regional, local, or global process improvement initiatives.
- Support Site Care Partner activities related to feasibility assessment, site selection, site activation planning, and study startup activities.
- Conduct co-monitoring activities when required.
Qualifications
- Bachelor's degree in Life Sciences or an equivalent healthcare-related discipline such as Nursing, Pharmacy, or Medicine.
- Extensive knowledge of clinical trial methodologies, ICH/GCP requirements, FDA regulations, and local country regulations.
- Minimum 3 years of clinical research site monitoring experience.
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
- Global clinical trial experience.
- Fluency in English and the local language(s) of the country of employment.
Knowledge, Skills and Competencies
- Strong knowledge of clinical research and clinical development processes.
- Strong understanding of regulatory requirements and clinical trial operations.
- Ability to evaluate, interpret, and communicate complex clinical and operational issues.
- Ability to work effectively in a matrix environment.
- Strong communication and stakeholder management skills.
- Ability to support regulatory inspections and audits.
- Understanding of protocol development, feasibility assessment, and risk management activities.
Travel Requirements
- Significant travel is required.
- Occasional international and weekend travel may be required.
- Valid driver's license and passport require
Work Location Assignment: Remote - Field Based
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