When our values align, there's no limit to what we can achieve. Drive study performance at the sites.
Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents.
Provide the required monitoring visit reports within required timelines.
Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
Contribute to the selection of potential sites and investigators.
Train, support and advise Investigators and site staff in study related matters.
Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations.
Manage study supplies, drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan.
Ensure data query resolution.
Work with data management to ensure quality of the study data.
Ensure accurate and timely reporting of Serious Adverse Events.
Share relevant information on patient recruitment and study site progress within local Study Team.
Update VCV and other systems with data from centres as per required timelines.
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.
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Clinical Research Associate Ii (fsp), Shanghai
Free
Clinical Research Associate Ii (fsp), Shanghai
China, 上海, 上海,
发表 March 14, 2025
描述
联系雇主
雇主信息
PAREXEL International is a leading global biopharmaceutical services provider, which continues to be a premier, trusted partner to clients who rely on the Company for expertise and flexibility, as well as the efficiencies of a worldwide infrastructure, to help them more quickly achieve their development and commercialization goals. For 30 years, PAREXEL has complemented client organizations with strategic insight, deep scientific knowledge, tactical expertise, and a wealth of experience throughout the development process. The Company's offerings include worldwide regulatory expertise, Phase I-IV clinical research services, eClinical technologies that accelerate development, and integrated commercialization services. PAREXEL is focused on providing tailored solutions that match a client's specific needs by applying the right blend of resources and capabilities, as well as the right guidance and high level of quality needed to help them bring safe and effective treatments to patients sooner.
Headquartered near Boston, Massachusetts, PAREXEL operates in over 70 locations throughout more than 50 countries, and has over 11,000 employees worldwide.
Visit www.PAREXEL.com for more information.
Specialties
Regulatory and product development consulting,
early phase clinical research,
phase II-III clinical research,
late phase clinical research,
eClinical solutions,
patient and site recruitment,
clinical logistics,
flexible outsourcing models,
strategic partnering
