(Sr.) Clinical Trial Operation Specialist

Job description

JOB DESCRIPTION:

Receive clinical trial regulation and GCP training. Coordinate blood centers for clinical trials and relevant studies; Maintain the clinical trial site database. Collect the clinical trial procedures, IRB documents, IRB/EC committee meeting information; Monitor on site of clinical trial. Coordinate and manage the blood centers to ensure the clinical trial operation in consolidated protocol and standards. Conduct clinical trials based upon the protocol. Train and assist the blood center operators during clinical trial if necessary. Coordinate and manage the sample collection, storage, testing and disposition. Manage the records including the sample information, assay information, instrument maintenance records, and archive original testing results. Coordinate supply chain to ensure the on-time shipment and archive shipment document. Conduct GCP self-inspection on site; Sr. specialist 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.

- Bachelor or above

- Background is with clinical laboratory medicine, immunology, clinical medicine or related specialties.
- Minimum 2 year working experience on clinical trial as CRA; and minimum 3 to 4 years working experience for Sr. specialist.

Clinical trial experience, technical support or registration experience of IVD is preferred.  

- Skills on English listening, speaking, and writing.

- Experience on GCP audit and inspection.

- Skills on statistical software and data analysis.

- Experience on the communication with CFDA/CMDE.

- Knowledge and experience in international standards (ICH/GCP), and local regulations;

- Knowledge on the new medical device, drug license and IVD GCP regulation and CT on-site inspection requirements;

- Global study experience is preferred.

- Prefer to MNC working or internship experiences.

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