Clinical Research Associate

hace 2 semanas

Bogotá, Bogotá D.E., Colombia IQVIA Argentina A tiempo completo

Job Overview

We are seeking a highly skilled Site Activation Specialist to join our team at IQVIA Argentina. The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines.

Key Responsibilities

  1. Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  2. Perform feasibility, site ID, start-up, and site activation activities according to applicable regulations, SOPs, and work instructions.
  3. Prepare site documents, reviewing for completeness and accuracy.
  4. Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  5. Review and provide feedback to management on site performance metrics.
  6. Review, establish, and agree on project planning and project timelines.
  7. Ensure monitoring measures are in place and implement contingency plans as needed.
  8. Inform team members of completion of feasibility, site ID, regulatory, and contractual documents for individual sites.
  9. Review, track, and follow up the progress, approval, and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

Requirements

  1. Bachelor's Degree in Life Science or related field.
  2. 2 or more years of experience in clinical research: site activation, regulatory, MoH's contact.
  3. 1 year experience in a leadership capacity is a plus.
  4. Fluent in English conversational (also written and read).

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