Senior Clinical Research Associate – FSP

🕒 Junho 9

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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• Has local responsibility for the delivery of the studies at allocated sites • Works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) • Acts as the main contact with the study site • Responsible for monitoring the study conduct to ensure proper delivery of the study • Responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies • Ensures compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations • Contributes to the selection of potential investigators • Trains, supports, and advises Investigators and site staff in study related matters • Confirms that site staff have completed and documented the required training appropriately • Ensures the sites are inspection ready at all times • Participates in Local Study Team (LST) meetings • Updates CTMS and other systems with data from study sites as per required timelines • Prepares study drug for destruction, if applicable • Ensures data query resolution in a timely manner • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required

🎯 Requisitos

• Proficient in written and spoken English language required • Fluency in local language(s) required • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP • Good knowledge of relevant local regulations • Good medical knowledge and ability to learn relevant Client Therapeutic Areas • Basic understanding of the drug development process • Good understanding of Clinical Study Management including monitoring, study drug handling and data management • 3+ years of experience as an on-site Clinical Research Associate (CRA) for the Senior CRA position and 1+ years of experience for the Clinical Research Associate role • Bachelor's degree in related discipline, preferably in life science, or equivalent qualification

🏖️ Benefícios

• Ability to travel nationally/internationally as Required