Job Description
Job Description
- Protocol Review: Review and understand the study protocol, which outlines the objectives, design, methodology, and conduct of the clinical trial.
- Site Selection: Participate in the selection of appropriate clinical trial sites and investigators based on their qualifications and ability to conduct the study.
- Regulatory Compliance: Ensure that the clinical trial is conducted in compliance with relevant regulatory requirements, including Good Clinical Practice (GCP) guidelines. Assist in the preparation for and conduct of regulatory inspections.
- Site Initiation: Conduct site initiation visits to train investigators and site staff on the protocol, regulatory requirements, and data collection procedures.
- Monitoring: Regularly visit clinical trial sites to monitor the conduct of the study, including the verification of data accuracy, participant safety, and protocol adherence.
- Data Collection and Management: O...