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Job Details
Clinical Research Associate (Field Based)
Permanent
Logistic and technical support to UK Clinical Studies Team, mainly to the Clinical Project Leaders (CPLs) and Clinical Studies Manager (CSM). The verification of technical and clinical data on-site for completeness and accurateness and validation of data through source data verification. Participation in study initiation under co-ordination of CPLs and CSM: set-up and review of essential documents for the successful running of clinical trials. Follow-up of clinical studies on site according data management plan and monitoring plan designed by the Clinical Departments (UK, Europe or US), including collection of clinical and technical data after verification of their accuracy and completeness with original documentation or source documents, as well as initiation of corrective actions to comply with clinical study purposes according to national and international laws, regulations and guidelines. Co-ordination of ethics committee and regulatory authority applications and approvals. Understand latest developments in good clinical practice and any applicable regulatory and/or legislative requirements as directed by Clinical Managers or Clinical Project Leader. Work closely with the Clinical Project Leader or Manager to support the conduct of assigned Clinical Study Projects in line with agreed clinical investigation plan and the requirements of the organisations quality control process. Perform administrative tasks to support successful progress of clinical studies including
