Site Activation Specialist in Brazil
2 semanas atrás
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 clinical research regulatory 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.LI-NRJ
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Site Activation Specialist in Brazil
Há 2 dias
Sao Paulo, Brasil IQVIA Tempo inteiroUnder 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...
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Site Activation Specialist
2 semanas atrás
São Paulo, Brasil IQVIA LLC Tempo inteiroSite Activation Specialist page is loaded## Site Activation Specialistlocations: São Paulo, Braziltime type: Full timeposted on: Posted Todayjob requisition id: R **Site Activation Specialist***Home-based: Brazil***Make an impact on patient health!**IQVIA’s Global Site Activation Team of 2000 employees, drives best in class site and customer experience,...
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Site Activation Specialist
2 semanas atrás
São Paulo, Brasil IQVIA Tempo inteiroSite Activation Specialist Home-based: Brazil Make an impact on patient health! IQVIA’s Global Site Activation Team of 2000 employees, drives best in class site and customer experience, with industry leading outcomes. We keep the patient at the forefront; ‘Always Impatient for the Patient’ and we excel in our collaboration with our external/internal...
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Site activation specialist
Há 7 dias
São Paulo, Brasil IQVIA Tempo inteiroSite Activation Specialist Home-based: Brazil Make an impact on patient health! IQVIA’s Global Site Activation Team of 2000 employees, drives best in class site and customer experience, with industry leading outcomes. We keep the patient at the forefront; ‘Always Impatient for the Patient’ and we excel in our collaboration with our external/internal...
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Site Activation Specialist
2 semanas atrás
São Paulo, Brasil IQVIA Tempo inteiroSite Activation Specialist Home-based: Brazil Make an impact on patient health! IQVIA’s Global Site Activation Team of 2000 employees, drives best in class site and customer experience, with industry leading outcomes. We keep the patient at the forefront; ‘Always Impatient for the Patient’ and we excel in our collaboration with our external/internal...
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Site Activation Specialist
Há 7 dias
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroSite Activation SpecialistHybrid: São Paulo, BrazilMake an impact on patient healthIQVIA's Global Site Activation Team of 2000 employees, drives best in class site and customer experience, with industry leading outcomes.We keep the patient at the forefront; 'Always Impatient for the Patient' and we excel in our collaboration with our external/internal...
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Site Activation Specialist
1 semana atrás
São Paulo, São Paulo, Brasil IQVIA Tempo inteiroSite Activation SpecialistHome-based: BrazilMake an impact on patient healthIQVIA's Global Site Activation Team of 2000 employees, drives best in class site and customer experience, with industry leading outcomes.We keep the patient at the forefront; 'Always Impatient for the Patient' and we excel in our collaboration with our external/internal...
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Sao Paulo, Brasil IQVIA Tempo inteiro**Job Overview**Under general supervision, **perform tasks at a country level associated with contracts for 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...
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Site Activation Specialist
1 semana atrás
São Paulo, Brasil IQVIA Tempo inteiroJob Overview IQVIA’s Global Site Activation Team of 2000 employees drives best‑in‑class site and customer experience, with industry‑leading outcomes. Make an impact on patient health! Location: Home‑based, Brazil We keep the patient at the forefront; “Always Impatient for the Patient” and we excel in our collaboration with our external/internal...
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Site Activation Specialist
1 semana atrás
Sao Paulo, Brasil IQVIA Tempo inteiroJob Overview Under general supervision, perform tasks at a country 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 - Under general...
