Clinical Research Associate – Site Director

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🕒 Maio 9

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Codera

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Codera é uma empresa B2B que faz parceria com empresas de biotecnologia e farmacêuticas para fornecer expertise e infraestrutura de desenvolvimento de medicamentos de ponta a ponta. Ela apoia clientes em todo o ciclo de vida do desenvolvimento de medicamentos com serviços técnicos, operacionais e infraestrutura para ajudar a avançar os programas terapêuticos.

Descrição

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites • Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines • Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies • Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites • Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines • Develop and cultivate strong site relationships and ensure continuity of site relationships • Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance • Identify, assess, escalate and resolve site performance or quality issues in a timely manner • Complete feasibility and site identification activities for new clinical studies • Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments) • Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions • Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance • Responsible for the development of site-specific recruitment, retention and follow-up plans • Facilitate and support investigator site audits and/or inspection activities as needed • Perform remote data review and query resolution for designated sites • Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives • Coach and mentor colleagues as needed • Contribute to the review of Codera’s systems and procedures as needed • May be involved, when needed, in other areas of study management and staff training • Execute other duties as assigned

🎯 Requisitos

• Bachelor’s Degree in a Life Science discipline required • Bachelor’s degree in nursing or RN a plus • Minimum 3 years of direct site monitoring experience required • Bilingual in English & French • Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required • Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations • Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes • Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle • Detail-oriented, organized and committed to quality and consistency • Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines • Excellent team-interaction skills and ability to work successfully in team settings • Ability to work in a dynamic environment with a high degree of flexibility • Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs • Excellent written and verbal communication skills • Experience and proven proficiency in CTMS and eTMF systems preferred • Must be willing and able to travel up to 50-65%

🏖️ Benefícios

• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs