Soon Yi Sor

- Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring
regulatory and protocol compliance. Visits may be performed on-site or remotely
- Review completion of proper informed consent procedures.
- Ensure accurate data reporting via review of site source documents and medical records
- Interpret data to identify protocol deviations and risks to subject safety/data integrity
- Generate queries and manage resolutions with site personnel
- Perform investigational product accountability as per the protocol and Study Monitoring Plan
- Evaluate execution of study protocol at the site level. Use judgement and experience to
evaluate overall performance of site and site staff and to provide recommendations regarding
site-specific actions
- Obtain, review and process essential regulatory and administrative documents. Conduct audits
of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
- Document activities via confirmation letters, follow-up letters, trial reports, communication logs,
and other required study documents as per SOPs and Study Monitoring Plan
-Act as primary liaison with study site personnel
-Maintain a working knowledge of ICH/GCP

- Manage the operational aspects of clinical research.
- Participate in protocol development, develop and review patient information sheet and informed
consent form.
- Assist in securing ethical approval, other regulatory requirements
- Conduct pre-study activities, SIV and SMV. Preparation of Investigator's meeting
- Coordinate effective communication between study sites and investigators
- Ongoing supervision of study sites to access compliance with protocol, sponsor, GCP and
regulatory requirements