Study start-Up and activation:
Conducts study start-up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activation
Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
Intelligence gathering
Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
Study conduct and closeout:
Compliance with Parexel standards:
Skills and Technical Competencies:
Behavioral Competencies:
Knowledge and Experience:
Education:
