Site Activation Partner - FSP

Join to apply for the Site Activation Partner - FSP role at Parexel

Overview

Join to apply for the Site Activation Partner - FSP role at Parexel .

Responsibilities

• Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site initiation
• Provide support to resolve issues or concerns and timely escalation of site issues where applicable
• Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572 / Attestation Form, for internal regulatory approval within required timeline
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements
• Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval (country dependent)
• Support investigators sites with local IRB workflow from preparation, submission through approval
• Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures

Knowledge, Skills and Experience

Knowledge And Experience

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Seniority level

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