诺维泰医药科技(上海)有限公司 Hiring! Full Time CRA in Hong Kong - Ricebowl

Responsibilities:

• Performing site evaluation, initiation, monitoring and close-out visits, plus maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP, and applicable regulations.

• Supporting the development of a subject recruitment plan.

• Establishing regular lines of communication plus administering protocol and related study training to assigned sites.

• Evaluating the quality and integrity of site practices - escalating quality issues as appropriate.

• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.

• Assist of country and/or site start up activities, including but not limit to country/site ICF development, preparation of IRB submission package, site contract and budget negotiation, and regulatory documents collection.

• Perform the tasks assigned by line manager.

Education and Experience:

• A BS (Bachelor of Science) degree in Life Sciences or a related field. Advanced degree is an advantage.