Site Activation Coordinator (North America team)

IQVIA Argentina; São Paulo; Presencial; BRL 67 000 - 100 000; Tempo integral

Resumo da oferta

IQVIA is seeking a junior Site Activation Associate to support feasibility studies and activation at regional and country levels. You will manage site documentation, track regulatory and ethics documents, and coordinate with sites and sponsors under supervision.

This role offers growth into regulatory and project management responsibilities within a global CRO setting. The ideal candidate has a Life Sciences degree, at least one year of clinical research experience, and strong English skills to

Qualificações

• Bachelor's Degree in Life Sciences or related field.
• At least 1 year of clinical research experience.
• Advanced English proficiency to work with North American sites.

Responsabilidades

• Serve as a Single Point of Contact (SPOC) for feasibility and site activation activities.
• Prepare and review site documents and contracts with sites and sponsors.
• Track progress and maintain project timelines and databases.
• Coordinate regulatory, ethics, and ICF related documents.
• Communicate completion of documents to team and sites.

Conhecimentos

SPOC responsibilities

Feasibility

Site Activation

Regulatory knowledge

Documentation review

Cross-functional collaboration

Formação académica

Bachelor's Degree Life sciences

Descrição da oferta de emprego

Job Overview

Under moderate supervision, executes the feasibility, site identification regulatory and start-up activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages 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. With moderate oversight and supervision, perform tasks at a country/region 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. May also include maintenance activities.

Essential Functions

• With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility and site activation 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. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications

• Bachelor's Degree Life sciences or a related field
• At least 1 year of clinical research experience
• Advanced level of English - you'll be working with North American sites

This is a junior role, ideal for anyone with some experience that wants to pivot to the site activation role or that wants to learn new things!

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 https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.