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Clinical Site Activation Coordinator in Chile
hace 2 meses
Job Overview
Execute responsibilities at a national level related to Site Activation (SA) functions in compliance with relevant local and/or international guidelines, standard operating procedures (SOPs), project specifications, and financial parameters. This role may also encompass maintenance tasks.
Key Responsibilities
• Operate under general supervision as the Single Point of Contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Manager (SAM), Project Management team, and other necessary departments. Ensure compliance with standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and adherence to project timelines.
• Conduct initiation and site activation tasks in accordance with applicable regulations, SOPs, and work instructions. Distribute finalized documents to sites and internal project team members.
• Prepare regulatory documents for sites, ensuring completeness and accuracy.
• Maintain accurate records and updates in internal systems, databases, and tracking tools with project-specific information.
• Analyze and provide feedback to management regarding site performance metrics.
• Collaborate on project planning and timelines, ensuring monitoring measures are established and contingency plans are implemented as necessary.
• Notify team members upon completion of regulatory and contractual documents for individual sites.
• Monitor, track, and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in alignment 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 interact directly with sponsors on specific initiatives.
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.
IQVIA is a premier global provider of advanced analytics, technology solutions, and clinical research services to the life sciences sector. We are committed to advancing human science and data science to maximize our impact – aiding our clients in fostering a healthier world. Learn more at