Taiwan Clinical Research Associate

Proclinical is working with a rapidly growing, global full-service Clinical Research Organization (CRO) that is seeking a Clinical Research Associate, to be based in Taiwan on a permanent basis.

Job Responsibilities:

• Coordinating and conducting internal project-level, process and system audits for MMD operations and supporting functions;
• Hosting audits by Sponsors and Regulatory Inspectors of the company; providing internal support and guidance on outcomes
• Coordinating, conducting, and tracking Regulatory Training (ICH/GCP, ISO);
• Involvement on the company QA Management in development and execution of strategic and tactical objectives focusing on continuous improvement of the company Quality System and QA Operations;
• Providing guidance and oversight of the company CAPA program working with outside clients/sponsors; and
• Other items as deemed necessary.

Skills and Requirements:

• Candidate must have a BA/BS (or a BSN) in Life Sciences;
• 3 - 5 years of experience in a QA department in a related industry required;
• Knowledge and application of GLP is required. GCP is a plus;
• Experience in conducting audits of device clinical trials, critical vendor assessments (e.g., IRB, Archiving, Clinical Labs); and thorough knowledge of Medical Device QMS requirements and QSIT
• Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;
• Independent thinking and planning ability;
• Excellent written and verbal communication skills; and
• Good teamwork skills, as well as the ability to work independently.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 3159 1467 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

R1215238 | EA13C6865

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