Site Activation Specialist

2 semanas atrás

Campo Grande, Brasil IQVIA Argentina Tempo inteiro

Overview

Our Site Activation Specialists work under moderate supervision, executing the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. You will prepare and manage site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.

Responsibilities
  • Serve as a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary
  • Review documents for completeness, consistency and accuracy, under guidance of senior staff
  • Prepare site documents, reviewing for completeness and accuracy
  • Inform team members of completion of regulatory, contractual, and other documents for individual sites
  • Distribute completed documents to sites and internal project team members
  • Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
  • Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Bachelor’s Degree in Life Science or related field
  • 1 - 3 years’ prior experience in life sciences or similar (or equivalent combination of education, training and clinical, healthcare and/or pharma experience) working with regulatory and start up activities is a must. Prior experience supporting US sites is highly valued.
  • Advanced level of English (you'll be working with North America on a daily basis)
  • Ability to work independently to problem-solve collaboratively and to raise issues appropriately as needed
  • Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors

Home based role, in Argentina or Brazil

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