Senior Clinical Research Associate

🕒 Abril 29

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions • Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports • Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents • If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate • Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements • Supports subject/patient recruitment, retention and awareness strategies. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

🎯 Requisitos

• 4-year college degree or equivalent experience in a scientific or healthcare discipline • 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies • Significant site management experience or equivalent experience in clinical research • Ability to communicate both verbally and in writing at the English proficiently (Professional level).

🏖️ Benefícios

• Health insurance • Professional development opportunities