Description
The Senior Clinical Research Associate II is responsible for site management, site monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.
The role involves managing investigator site relationships, ensuring effective delivery of clinical trials, safeguarding the quality of investigator sites, and enhancing the company's image with external stakeholders.
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 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 database lock.
- Serve as the primary point of contact for assigned investigator sites and work in partnership with the Site Care Partner.
- Interface with the study team, facilitate information flow between members of the study team, vendors, and assigned investigator sites.
- Partner with the Site Care Partner 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.
- Conduct onsite, remote, or electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities.
- Monitor site-level adverse events and serious adverse events 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 plans.
- Ensure adequate oversight of the investigational product at the investigator site.
- 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 facilitate clinical development goals.
- Support the study clinician in ensuring patient safety, eligibility, and providing clinical guidance to investigators.
- Drive Quality Event remediation when applicable.
- Other:
- Mentor/training Clinical Research Associates and Senior Clinical Research Associates I.
- Serve as a subject matter expert for CRA-related processes.
- Participate in or lead global, regional, or local working groups/process improvement initiatives.
- Perform the duties of a Site Care Partner for small projects or under guidance of a Site Care Partner in larger projects.