Responsibilities:
1) Evaluate potential sites and provide PM with recommendations for selection of qualified sites.
2) Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
3) Prepare and manage the clinical trial agreements with investigators/sites.
4) Monitor and report the project status at the sites in a timely manner.
5) Maintain essential documentation in compliance with ICH-GCP, local regulations both in the office and at site.
6) Manage study supplies (ISF, CRF, etc.), drug supplies and drug accountability at study sites.
7) Assist the investigator for auditing/inspection of project.
8) Ensure completeness and quality of data in the investigational sites.
9) Proactively identify study-related issues and escalates as appropriate.
10) Performs other duties as assigned.
Qualifications:
1) Bachelor’s degree or above in a scientific or health-related field.
2) CRA: above 2 years of relevant clinical research experience.
Senior CRA: above 3 years of monitoring experience. Demonstrate leadership skill, mentor, and coach capability, able to work independently.
3) Knowledge of Good Clinical Practice, ICH guidelines
4) Fluent in English.