Site Activation Specialist (For Us Sites) In Argentina Or Brazil

buscojobs Brasil; São Paulo; Teletrabalho; BRL 15.000 - 20.000; Tempo integral

Resumo da oferta

A leading clinical research organization is seeking a Site Activation Specialist based in Brazil. This role involves managing site documentation and ensuring compliance with regulations. The ideal candidate will have a Bachelor's Degree in a Life Science, 1-3 years of relevant experience, and advanced English skills. This position allows for home-based work, providing flexibility along with the chance to work with North American teams.

Qualificações

• 1 - 3 years prior experience in life sciences or equivalent.
• Experience with regulatory and start-up activities required.
• Ability to work independently and problem-solve collaboratively.

Responsabilidades

• Perform feasibility, site activation, and maintenance activities.
• Prepare and review site documents for completeness and accuracy.
• Track and follow up document approvals and executions.

Conhecimentos

Regulatory compliance

Interpersonal communication

Organizational skills

Problem-solving

Project management

Advanced English

Formação académica

Bachelor’s Degree in Life Science or related field

Descrição da oferta de emprego

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

Qualifications

• 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 valuated.
• 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!

LI-NRJ #LI-Remote

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at