Site Activation Specialist (North America Team) PCD

IQVIA; São Paulo; Presencial; BRL 89 000 - 179 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

PCD position

Resumo da oferta

IQVIA is seeking a Site Activation Professional to support feasibility, site activation, and maintenance activities for investigative sites. You will collaborate with SAM, PM teams, and other departments to ensure documents are complete, accurate, and properly distributed across sites.

The role requires 1-3 years in clinical research, a Life Sciences degree, and advanced English. Based in Brazil or Argentina, you will interact with North American teams and follow SOPs to meet project timelines.

Qualificações

• Based in Argentina or Brazil.
• Bachelor's Degree Life sciences or a related field required.
• 1-3 years’ clinical research supporting site activation/regulatory tasks.
• Advanced level of English. Working with a US team and North American sites.

Responsabilidades

• Serve as SPOC for feasibility, site activation and maintenance activities.
• Prepare site documents and review for completeness and accuracy.
• Inform team of completion of regulatory and other documents for sites.
• Distribute completed documents to sites and project team members.
• Update and maintain project plans and tracking tools with accurate information.
• Review and track regulatory, ethics, ICF and IP release documents.

Conhecimentos

SPOC responsibilities

Clinical research

Regulatory awareness

English proficiency

Formação académica

Bachelor's degree Life sciences

Descrição da oferta de emprego

Job Overview

Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance 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, 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 questionaires, 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

• Based in Argentina or Brazil.
• Bachelor's Degree Life sciences or a related field required.
• Other 1 - 3 years’ clinical research supporting site activation/regulatory tasks.
• Advanced level of English. You will be working with a team from the US and interacting with North American sites.

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. .

Vaga Exclusiva para Pessoa com deficiência (PCD)