Key Accountabilities:
Oversight of Monitoring Responsibilities and Study Conduct
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
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
Partner with 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
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to 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 investigators 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
Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
Clinical/Scientific and Site Monitoring Risk
Collaboration
Compliance with Parexel standards
Skills:
Knowledge and Experience:
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
Education:
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