Lead Clinical Research Associate

🕒 6 dias atrás

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PSI CRO AG

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1996

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

PSI CRO AG é uma organização global de pesquisa por contrato (CRO) especializada na condução de ensaios clínicos. A empresa foca na entrega de ensaios clínicos pivotais de Fase 2 e Fase 3 em diversas áreas terapêuticas, incluindo Doenças Inflamatórias Intestinais, Oncologia, Hematologia, Doenças Infecciosas, Esclerose Múltipla e Doenças Raras. A PSI utiliza uma plataforma tecnológica proprietária para planejamento de ensaios clínicos e controle financeiro, garantindo que os estudos sejam conduzidos no prazo e dentro do orçamento. A empresa é reconhecida por sua expertise, qualidade, compatibilidade e confiabilidade, tendo sido premiada no CRO Leadership Awards por vários anos consecutivos.

Descrição

• Oversee and guide the clinical team while driving trial activities at country or regional level • Monitor project timelines, patient enrollment, data cleaning, compliance, and corrective and preventive measures • Review monitoring visit reports and ensure regional reporting compliance • Coordinate communication among Monitors, Site Management Associates, Regional Project Leads, and Project Managers • Lead country-level project team calls and provide status updates and reports • Provide project-specific training and prepare training materials • Supervise source data verification, data-query follow-up, and site-level study-risk management • Ensure proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies • Review essential study documents and supervise ISF/TMF reconciliation • Ensure site-level data integrity and compliance • Collaborate on investigator/site feasibility, site identification, and study startup • Manage query resolution, including Central Monitoring observations • Coordinate safety-information flow and protocol/process-deviation reporting • Manage clinical supplies with vendors at country and regional levels • Keep study-specific and corporate tracking systems updated • Coordinate supervised monitoring visits and conduct visits • Manage site contracting and payments • Conduct audit preparation visits, participate in site audits, and coordinate resolution of findings • Oversee CAPA development and implementation • Coordinate process-deviation review, management, and reporting • Conduct initial training and authorization monitoring visits for Monitors • Mentor newly promoted Lead CRAs • Deliver training and presentations at Investigator Meetings • Ensure subject-recruitment targets and project timelines are defined, communicated, recorded, and met • Ensure timely information flow with trial sites regarding Adverse Events and protocol/process deviations • Supervise Site Management Associates handling documents and laboratory supplies • Support preparation of regulatory and ethics committee submission packages

🎯 Requisitos

• Relevant educational background such as MD, MPharm, RN, or a college/university degree in Life Sciences, or equivalent combination of education, training, and experience • Minimum 4 years of site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level • Experience monitoring sites in the US • Experience with all types of monitoring visits in Phase II and/or III • Strong experience in Oncology preferred • Experience in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other Cell Therapy, Gene Therapy, or Nuclear Medicine preferred • Strong experience in GI (Crohn's, Ulcerative Colitis, IBS) preferred • Full working proficiency in English • Proficiency in MS Office applications • Ability to plan, multitask, and work in a dynamic team environment • Excellent communication, collaboration, and problem-solving skills • Ability to travel • Must not require a work visa for employment or continued employment now or in the future

🏖️ Benefícios

• Remote work • Low-travel model • Confidential handling of applicant information according to EEO guidelines