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Clinical Site Activation Coordinator in Chile
hace 2 meses
Position Summary
The role involves executing tasks at a national level related to Site Activation (SA) processes, ensuring compliance with relevant local and international regulations, standard operating procedures (SOPs), project specifications, and budgetary constraints. This may also encompass ongoing maintenance responsibilities.
Key Responsibilities
• Act as the primary contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Managers (SAM), Project Management teams, and other relevant departments. Uphold adherence to SOPs, Work Instructions (WIs), quality standards for deliverables, and project timelines.
• Execute start-up and site activation tasks in accordance with applicable regulations, SOPs, and work instructions. Ensure the distribution of completed documentation to sites and internal project stakeholders.
• Prepare and review site regulatory documents for completeness and accuracy.
• Maintain accurate records and updates in internal systems, databases, and tracking tools with project-specific information.
• Analyze site performance metrics and provide constructive feedback to management.
• Collaborate on project planning and timelines, ensuring monitoring measures are established and contingency plans are implemented as necessary.
• Notify team members upon the completion of regulatory and contractual documents for individual sites.
• Monitor and follow up on the progress of approvals and execution of documents, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) release documents, aligning with project timelines.
• Offer local expertise to SAMs and project teams during initial and ongoing project timeline planning.
• Conduct quality control checks on documents submitted by sites.
• May engage directly with sponsors on specific initiatives.
Required Qualifications
• Approximately 1 year of experience in clinical research or a comparable combination of education, training, and experience.
• Proficient in English at an intermediate to advanced level.
• Strong communication and interpersonal skills are essential.
IQVIA stands as a premier global provider of advanced analytics, technology solutions, and clinical research services within the life sciences sector. Our mission is to push the limits of human and data science to create significant impacts, aiding our clients in fostering a healthier world. Discover more about us at
