Site Care Partner – Min 6+ years experience in Oncology

🕒 Setembro 4

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🪙 Gerente de Afiliados

👻 Score fantasma 10%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely • Evaluate site and site staff performance and provide recommendations on site-specific actions • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data entered in CRFs • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical study data review and capture; verify EDC compliance • Manage investigational product inventory, reconciliation, storage, security, dispensing and administration compliance • Review Investigator Site Files and reconcile them with Trial Master Files • Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, ongoing status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as liaison with study site personnel and ensure assigned sites and project-specific team members are trained and compliant • Attend investigator, sponsor, clinical monitoring and training meetings • Support audit readiness, audit preparation and follow-up actions • Provide supervision, training and mentorship to junior CRAs; perform training and sign-off visits • For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsors and affiliates, identify potential sites, improve processes, develop informed consent forms, support regulatory activities, participate in bid defense, RFP, budgeting, CRF design and edit check development

🎯 Requisitos

• Minimum 6+ years of previous monitoring experience • Oncology monitoring experience ideally • Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Moderate level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes • Ability to perform site qualification, initiation, monitoring, management and close-out activities on-site or remotely • Ability to work with clinical data, source documents, medical records, CRFs, EDC systems, ISF and TMF • Ability to manage site-level activities, communications, project objectives, deliverables and timelines

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, equity, and inclusion-focused workplace culture