Senior Clinical Research Associate 資深臨床研究專員 (Senior CRA)
Posted 4
views
Description
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Proform study monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to GCP and applicable regulations.
- Escalate quality issues to Project Manager (PM), Clinical Research Associate Leader (CRA Leader, if applicable), Quality Assurance (QA), Quality Management (QC) and/or Line Manager (LM) as required.
- Actively participate in study team meetings and department meetings.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans in compliance with ICH-GCP, procedural documents and local regulations both in the office and at site.
- Act as a mentor of junior clinical staff including conducting co-monitoring, performance assessment and training visits, as assigned.
- Act as CRA Leader to lead CRA team when assigned.
- Capable on acting as a Project Leader role to manage the project at country level, as directed.
- May provide assistance to the Project Manager with design of study tools, documents and processes; assist the project documents review as assigned.
- Ensure compliance with company policies and procedures relating to people, finance, technology, and security at Company and the site.
- Perform other duties as assigned.