Job Scope:
Pre-Study
- Coordinate study start-up activities, including assisting with feasibility reviews and furnishing of regulatory documents
- Plan, organize and coordinate the workflow of the study
- Development of materials and tools required for study start-up
- Coordinate all mandatory training requirements and documentation
Study Recruitment and Conduct
- Assisting with informed consent process by providing information to and educating research subjects, data collection and surveys
- Coordinate all relevant subject visits, ensuring minimum deviation from schedule of visits
- Ensure projects can be completed within the time frame and facilitate smooth running of research projects
- Assist PI to ensure timely amendments to study documents when required
Study Monitoring, Audit and Inspection
- Monitor the quality of research ensuring compliance with HBRA, GCP, ICH guidelines and standards
- Conduct monitoring visits including Remote Monitoring and Site Monitoring
- Assist with all external monitoring, audit and inspection visits
- Monitor the financial aspects of the assigned study and advise the stakeholders accordingly
- Work with PI and department to respond to any audit findings and implement approved recommendations
Study Closure
- Assist with study closure activities including archival and assisting with all audits/ inspections/ monitoring
- Ensuring proper closure of study with all ethics and regulatory authorities
- Ensuring proper archiving of all study records including medical records, study documents, investigator files, subject files etc
Job Requirements:
- Min. Degree in Science
For interested applicants, please send your updated resume to: [email protected]
All candidates’ information will be treated with the strictest confidence
Melissa Zhang Zhiqi (Mezzo)
R2197564
Recruit Express Pte Ltd
99C4599