Site Care Partner I

2 weeks ago

Perth, Western Australia Parexel International Full time

Key Accountabilities
Site start-up and activation
Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide Pre-Trial Assessment (PTA) output for site selection
Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision
Maintains a knowledge of assigned protocols
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.)
Supports country specific ICD review and deployment up to Site Activation
Ensures follow up activities' completion post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV)
Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV
Responsible for relationship building and operational quality of the site · Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners
Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and

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