13 ago
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Parexel
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México
Parexel FSP is hiring a Site Activation Partner in Mexico, Argentina or Brazil Candidates must have at least 3 years of experience in start-up working with US/Canada.
The Site Activation Partner (SAP) is responsible for leading or supporting operational activities from start- up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.
Organizational Relationships:
Reports to Parexel-assigned Line Management with day-to-day direction from Client; refer to Organizational Chart for details regarding assigned role and associated reporting structure.
Primary Responsibilities:
Clinical Trial Site Activation
- 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
- Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
- Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
- Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinat
📌 Site Activation Partner I (México)
🏢 Parexel
📍 México