(Sr.)Clinical Trial Operation Specialist

Primary Function

职责概述

To response for regulatory clinical trial and be a key initiator of related activities to ensure the clinical trials are conducted on time and operation in compliance.

Major Responsibilities

主要职责

• To support manager to coordinate new sites for clinical trials; Evaluate new site capability and compliance.
• To manage the clinical trial site database. Collect and analyze the clinical trial procedures, IRB documents, IRB/EC frequency, contract information; Monitor on line of clinical trial.
• Coordinate and manage the locked sites to ensure the clinical trial operation in unique protocol and standard.
• Draft clinical trial protocol to meet the regulatory regulation and guideline. Adjust the supplementary requirement of authorization agency on clinical trial.
• Coach the CT persons and actualize the CT operation when necessary.
• Response the CT sample management and adjustment.
• To make order for clinical trial assays and coordinate with supply chain to ensure the on-time shipment. Original document and data management and archive.
• Explain to evaluation expert if necessary. Monitor on line of clinical trial.
• Receive clinical trial regulation and GCP training.
• Must deal with the self-inspection, prepare for the on-site inspection and its related document preparation. To ensure all steps are on-time, included but not limited the IRB approval, contracts, filing, sample collection and testing, signature and stamp etc. To ensure the feasibility and quality of clinical trial protocol.

Requirement(education, background,…etc)

要求

• Bachelor or above
• Background is with Clinical Laboratory immunology, clinical medicine or related specialty.
• Minimum 3 to 5 years Clinical trial experience, technical support or registration experience of IVD is preferred. 
• Skills on English listen, speak, writing.
• Experienced on statistical software is preferred.
• Expertise in communication, managing multiple priorities and computer literacy.
• Knowledge and experience in international standards (ICH/GCP), and local regulations;
• Global study experience is preferred.
• Prefer to MNC working or internship experiences.