FSP - Regulatory and Start-Up Specialist in Brazil

IQVIA Argentina; São Paulo; Teletrabalho; BRL 12.000 - 20.000; Tempo integral

Resumo da oferta

A leading global provider of clinical research services seeks a Site Activation Coordinator for a home-based role. This position involves managing site activation tasks and ensuring adherence to regulations and project timelines. Ideal candidates will have a Bachelor's in Life Sciences and relevant experience, with strong communication skills and the ability to manage multiple projects effectively.

Qualificações

• 1-3 years' experience in Regulatory and Start-up activities.
• Advanced level of English.

Responsabilidades

• Serve as Single Point of Contact for assigned studies.
• Perform start-up and site activation activities.
• Ensure accurate completion of internal systems and documentation.

Conhecimentos

Regulatory compliance

Project management

Communication

Quality control

Formação académica

Bachelor's degree in Life Sciences

Descrição da oferta de emprego

Perform 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. May also include maintenance activities.

Essential Functions
• 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. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications
• Bachelor's degree in Life Sciences ideally
• 1-3 year's experience in Regulatory and Start up:

• ICF customization
• Amendments submission to Centro Coordenar and CONEP and to all participant sites
• ANVISA experience

• Advanced level of English

• Home based role

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