SCRA

2024-09-18

Responsibilities:

1.Organize the project team to conduct clinical trials, participate in the selection of clinical trial regions, centers, and principal investigators, conduct feasibility assessments; participate in the selection and bidding process of third-party clinical trial service providers;

2.Be responsible for the operational management of clinical trials, formulate reasonable project management plans and implement them, ensure that clinical trial activities are carried out in accordance with applicable standard operating procedures, trial protocols, and relevant laws and regulations;

3.Communicate and coordinate with clinical research service providers, control the service content, and manage the progress and quality of clinical trials;

4.Integrate and coordinate project resources, identify and assess risks throughout the clinical trial process, and adjust risk plans and measures as necessary;

5.Review clinical trial core documents, clinical trial agreements, monitoring reports, clinical trial reports, and other project-related plans and reports submitted by suppliers;

6.Other unspecified matters related to the job.

Requirements:

1.At least 3 years of relevant industry experience;

2.Familiar with relevant laws and regulations related to clinical trials; familiar with the clinical trial process and familiar with the key points in clinical trials;

3.Able to identify and propose solutions to various trial and operational problems, with excellent data monitoring capabilities;

4.Have a strong understanding of clinical trial protocols;

5.Able to train various researchers, CRCs, and other trial-related personnel, with strong communication skills.