Senior CRA I

🕒 Ontem

🇲🇽 México – Remoto

⏰ Tempo Integral

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend site-specific actions • Communicate and escalate serious issues and develop action plans • Verify informed consent processes, subject confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms and resolve queries • Review investigational product inventory, reconciliation, storage, security, dispensing and administration • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, status and action items to resolution • Manage site-level activities, communications, objectives, deliverables and timelines • Liaise with study site personnel and ensure site teams are trained and compliant • Attend investigator, sponsor, monitoring, project and clinical training meetings • Support audit readiness, audit preparation and follow-up actions • Provide site support throughout the study lifecycle, including site identification through close-out • Perform chart abstraction and data collection • Collaborate with sponsor affiliates, medical science liaisons and local country staff • Train junior staff when requested • Identify and communicate out-of-scope activities • Suggest potential sites based on local treatment patterns, patient advocacy and healthcare provider associations

🎯 Requisitos

• 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 • Ability to manage required travel of up to 75% on a regular basis • Knowledge of local requirements for real world late phase study designs • Ability to perform chart abstraction activities and data collection • Ability to collaborate with Sponsor affiliates, medical science liaisons and local country staff

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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