Lead Clinical Research Associate

🕒 Junho 4

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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

• Coordinates investigator/ site feasibility and identification process, as well as study startup. • Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. • Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. • Manages Monitors in the query resolution process, including Central Monitoring observations. • Coordinates safety information flow and protocol/process deviation reporting. • Performs clinical supplies management with vendors on a country and regional level. • Ensures study-specific and corporate tracking systems are updated in a timely manner. • Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. • Coordinates planning of supervised monitoring visits and conducts the visits. • Manages the project team in site contracting and payments. • Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. • Ensures ongoing evaluation of data integrity and compliance at a country/regional level. • Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. • Oversees project team in CAPA development and implementation. • Coordinates project team in process deviations review, management and reporting. • Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. • Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. • Delivers trainings and presentations at Investigator Meetings. • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. • Ensures data integrity and compliance at a site level. • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. • Conducts project-specific training of site Investigators. • Supports preparation of draft regulatory and ethics committee submission packages.

🎯 Requisitos

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. • Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. • Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices. • Experience with all types of monitoring visits in Phases I-III. • Strong experience in Oncology preferred. • Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. • Strong experience in GI (Chron'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 up to 65% (depending on project needs). • Valid driver’s license (if applicable).

🏖️ Benefícios

• Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.