Clinical Research Specialist en Chile

hace 1 semana


Santiago, Metropolitana, Chile IQVIA A tiempo completo

Job Overview

As a Clinical Research Specialist, you will be responsible for performing tasks at a country level associated with Site Activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. You will work closely with the Site Activation Manager, Project Management team, and other departments to ensure adherence to SOPs, quality of designated deliverables, and project timelines.

Key Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, ensuring adherence to SOPs, Work Instructions (WIs), and quality of designated deliverables.

• Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions, distributing completed documents to sites and internal project team members.

• Prepare site regulatory documents, reviewing for completeness and accuracy.

• Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.

• Review and provide feedback to management on site performance metrics.

• Review, establish, and agree on project planning and project timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.

• Inform team members of completion of regulatory and contractual documents for individual sites.

• Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

• Provide local expertise to Site Activation Managers and project team during initial and on-going project timeline planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

Requirements

• Around 1 year of clinical research experience, equivalent combination of education, training, and experience.

• Intermediate/Advanced level of English.

• Good communication and interpersonal skills.

#LI-NRJ #LI-Remote

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://www.iqvia.com/



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