Senior Clinical Research Associate

Proclinical is excited to announce a new vacancy for a home-based Senior CRA role in Taiwan. This is a great chance to join a passionate, innovative and committed team and make some positive contributions to medicine.

Job Responsibilities

• Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
• Performs site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
• Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical records
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).

Skills and Requirements

• Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment is essential.
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
• You will be educated to degree level in a life science discipline or be a licensed healthcare professional.

To Apply

Please click on the Apply button.

In case you have difficulty in applying or if you have any questions, please contact Mandy Fang on m.fang@proclinical.com.sg or upload your CV on our website - www.proclinical.com/send-cv

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