FSP - Regulatory and Start-up Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

Under moderate supervision, the Site Activation Specialist 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.

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 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

• 1 - 2 years of experience in a regulatory role in a CRO or pharma (not sites) and the following particular experience:

  • CEP/CONEP - initial submission for Main Site and remaining sites, amendments to Main Site and Remaining sites, Notifications;

  • ICF - Review and adaptation of local requirements (Country customization);

  • ANVISA (MoH) - Initial DEEC Submission, Substantial Protocol Amendments, FAEC Update (Anvisa Clinical trial Form), annual study report (DEEC), Annual Safety Report (DDCM)


• Advanced level of English skills


• Great communication skills and ability to work in a team.

This is a hybrid role.

Offices are located in Sao Paulo, SP.

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

  • FSP - Regulatory and Start-up Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, the Site Activation Specialist 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...

  • FSP - Regulatory and Start-up Specialist

    1 dia atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, theSite Activation Specialistexecutes 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...

  • FSP - Sr. Regulatory and Start Up Specialist in Brazil

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    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...

  • FSP - Sr. Regulatory and Start Up Specialist in Brazil

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Sao Paulo, Brazil | Full time | Home-based | R1518042Perform 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...

  • Study Start up Associate

    Há 3 dias

    São Paulo, São Paulo, Brasil ICON Strategic Solutions Tempo inteiro

    Study Start up Associate - São PauloICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Study Start Up Associate I to join...

  • Start Up Associate

    2 semanas atrás

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Job OverviewPrimary contact with investigative sites during study maintenance and -when assigned-, site startup activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site...

  • Study Start Up Associate II

    2 semanas atrás

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro

    Study Start Up Associate II - Homebased - Portuguese required - Brazil and MexicoICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently...

  • 500255 Study Start Up Associate I

    2 semanas atrás

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro

    Study Start Up Associate - São PauloICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Study Start Up Associate I to join our...

  • Regulatory Affairs and Licensing Specialist

    1 dia atrás

    São Paulo, São Paulo, Brasil Tether Operations Limited Tempo inteiro

    Join Tether and Shape the Future of Digital FinanceAt Tether, we're not just building products, we're pioneering a global financial revolution. Our cutting-edge solutions empower businesses—from exchanges and wallets to payment processors and ATMs—to seamlessly integrate reserve-backed tokens across blockchains. By harnessing the power of blockchain...

  • Study Start Up Associate

    1 semana atrás

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro

    Study Start Up Associate (Level I, II or Senior) - Contracts and budgets - Homebased - BrazilICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are...