Site Activation Specialist PCD

IQVIA; São Paulo; Presencial; BRL 60 000 - 90 000; Tempo integral

Resumo da oferta

IQVIA is seeking a site activation specialist to support feasibility, site identification, regulatory steps, start-up, and maintenance activities in regional or country programs. You will manage site documents, coordinate with sites and sponsors, and ensure contracts are fully executed within project timelines.

Under moderate supervision, you will partner with the SAM and project management teams, review regulatory documents such as ethics approvals and IP releases, and maintain accurate

Qualificações

• Bachelor's Degree Life Sciences or related field.
• 1-3 years' clinical research or equivalent experience.
• 3 years' experience in a healthcare environment or equivalent.

Responsabilidades

• Serve as SPOC for feasibility, site activation and some maintenance activities.
• Prepare and review site documents for completeness and accuracy.
• Inform team of document completion and share with sites and project team.
• Update tracking tools and project plans with accurate data.
• Review and follow up on regulatory, ethics, CDA, and ICF-related documents.

Conhecimentos

SPOC (Single Point of Contact)

Regulatory documentation

Project coordination

SOPs compliance

Formação académica

Bachelor's Degree Life Sciences or related field

Descrição da oferta de emprego

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, werve 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.

Qualifications

• Bachelor's Degree Life sciences or a related field Req And
• Other 1 - 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience. Req
• With 3 years' experience in a healthcare environment or equivalent combination of education, training and experience.

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.comIQVIA 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)