Site Monitor II - Clinical Research Associate II - Oncology Experience Required

5 days ago

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• Responsible for data integrity, data quality, and ensuring compliance with ICH GCP and local requirements. • Collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready. • Conduct monitoring activities using different methods, both on-site and remote. • Conduct source document review and verification of appropriate site source documents and medical records. • Manages reporting of protocol deviations and appropriate follow up. • Verifies the Investigational Product has been dispensed and administered according to the protocol. • Ensures all activities are managed by site personnel who are appropriately delegated and trained. • Enters data into tracking systems as required to track all observations and ongoing status. • Collaborates with primary Site Manager, prepares for and attends Investigator Meetings. • Participates in global clinical monitoring and project staff meetings.

Requirements

• 3 years minimum previous Oncology monitoring experience. • Networking and relationship building skills. • Ability to communicate effectively and appropriately with internal and external stakeholders. • Ability to adapt to changing technologies and processes. • Effectively overcoming barriers encountered during the implementation of new processes and systems. • Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization. • Identifies and builds effective relationships with investigator site staff and other stakeholders. • Proficiency in local language is required. • Advanced level or fluency in English is required.