Clinical Trials Associate Project Manager

🔥 9 horas atrás

🗽 New York – Remoto

infoinfo

💵 $65.000 - $85.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👷‍♀️ Gerente de Projetos

🚫👨‍🎓 Sem graduação necessária

👻 Score fantasma 0%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Rochester Regional Health

10.000+ funcionários

🏥 Saúde

⚕️ Seguro de Saúde

📚 Educação

Healthcare • Healthcare Insurance • Education

Rochester Regional Health é uma organização integrada de serviços de saúde que atende a população do oeste de Nova York. Opera múltiplos hospitais e unidades de saúde, oferecendo uma ampla gama de serviços de saúde, incluindo atendimento de emergência, cuidados primários, clínicas especializadas e atendimento de urgência. A organização é comprometida com a educação médica e a pesquisa, oferecendo programas de treinamento, residências e ensaios clínicos. Rochester Regional Health foca em cuidados abrangentes com ênfase no tratamento respeitoso dos pacientes e na satisfação de suas diversas necessidades médicas em todas as fases da vida.

Descrição

• Liaise with ACM Global Central Laboratory clients and represent laboratory aspects of clinical trials • Liaise internally with all groups to ensure trials are conducted according to the Global Laboratory Specification Document • Manage assigned low-complexity clinical trials from study setup through maintenance and closeout • Serve as the client’s primary point of contact and maintain customer service and satisfaction • Review clinical protocols and assist with protocol setup • Develop or support Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions • Participate in and support quality audits and clinical trial inspections • Evaluate and communicate monthly project metrics and analyze trial activity, including monthly budget review • Ensure client goals and timelines are met; troubleshoot and solve problems • Perform assigned on-call coverage duties • Manage regulatory study documentation, including collection, maintenance, and archiving • Develop protocol-specific procedures as needed • Provide project management administrative support and perform other assigned duties

🎯 Requisitos

• Minimum of 1 year of experience working in a clinical trials, laboratory or health care setting required • Excellent problem solving and communication skills • General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as they pertain to central laboratory functions • Ability to understand and follow company policies and procedures while maintaining patient and client confidentiality • Ability to perform sedentary, primarily office-based work with prolonged sitting and minimal physical effort • Associate’s degree strongly preferred (not required)

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