Description
The Senior Clinical Research Associate is responsible for site management, site monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.
Job Responsibilities
- 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.
- 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 and facilitate information flow between members of the study team, vendors, and assigned investigator sites.
- Partner with SCP to perform investigator site development, coaching, and training of site personnel.
- Attend investigator meetings when required.
- 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.
- Resolve data queries within required timelines and prepare investigator site close-out plan.
- Clinical/Scientific and Site Monitoring Risk:
- Maintain thorough understanding of the product, protocol, and therapy area.
- Interact with investigator site healthcare professionals to enhance Pfizer's credibility and scientific leadership.
- Support the study clinician in ensuring patient safety, eligibility, and providing clinical guidance to investigators.
- Drive Quality Event remediation, when applicable.
- Other:
- 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.
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.
- Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring.
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
- Global clinical trial experience.
- Must be fluent in both English and Mandarin.
Physical/Mental Requirements
- Advanced knowledge of clinical research and development processes.
- Demonstrated knowledge of global and local regulatory requirements.
- Advanced understanding of key operational elements of clinical research.
- Proven ability to work in a matrix team environment.
- Significant travel (60-80%) within area is required.