Clinical Research Associate

1. Job Purpose:

• This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations;
• The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2. Responsibilities:

• Study site selection, initiation (SIV) and clinical monitoring;
• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements;
• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements;
• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files;
• Prepare/complete study records’ archiving according to protocol and sponsor requirements;
• Ensure safety information is disseminated to all sites according SOP and applicable regulations;
• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations;
• Finalize budget and obtain signed contract from site, prior to site initiation visit;
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts;
• Update and maintain Study tools/systems in a timely manner.

3. Qualifications:

• Bachelor degree or above in Medical, Pharmacology or Biology related major;
• Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
• At least 1-2 years of CRA experiences;
• Good command of written and verbal English;
• Good skills on Microsoft Word, Excel, PPT and Outlook, etc.;
• Other abilities such as Communication skills/Information-gathering skills. Knowledge and/or experience in medical practice is a plus.

Welcome passion and creative ideas' friends! Look forward to receiving your CV.