Senior Clinical Research Associate I

The Senior Clinical Research Associate I is responsible for the site management, site monitoring and closeout of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards. The role is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders.

Responsibilities include:

• Responsible for investigator site management and monitoring for assigned sites.
• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met.
• Serve as the primary point of contact for assigned investigator sites during study conduct.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients.
• Provide protocol training to, and address protocol related questions from the investigator site staff when required.
• Attend investigator meetings when required (virtual or F2F).
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.
• 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.
• Ensure adequate oversight of the investigational product at the investigator site.
• Support database release as needed.
• May undertake the responsibilities of an unblinded monitor where appropriate.

Qualifications:

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Minimum 3 years relevant experience in clinical research site monitoring (some experience in Oncology preferred).
• Must be fluent in English and in the native language(s) of the country they will work in.

Physical/Mental Requirements:

• Demonstrated knowledge of clinical research and development processes.
• Proven ability to work in a matrix team environment.
• Effective verbal and written communication skills.

Non-standard Work Schedule, Travel or Environment Requirements:

• Significant travel (60-80%) within area is required.
• May require some international travel and some weekend travel.