Senior Clinical Research Associate - FSP

Key Accountabilities

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client 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.
• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and / or elevate to the SCP to ensure quality of site delivery.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and the assigned investigator sites.
• Partner with the SCP 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, including discussions on known / anticipated operational and clinical trial risks.
• Attend investigator meetings when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with the SCP and the study team to define and support recruitment initiatives at site level.
• Conduct onsite, remote / electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted in accordance with the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies.
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow up with investigator sites, as needed, to bring SAE reports required information to resolution.
• Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow-up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics.
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence / persistence of issues.
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines.
• Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.
• Support database release as needed.
• May undertake the responsibilities of an unblinded monitor where appropriate.

Clinical / Scientific and Site Monitoring Risk

Collaboration

Compliance with Parexel Standards

Skills

Knowledge And Experience

Education

#J-18808-Ljbffr