- Schedule and perform on-site or remote monitoring visits including SIV, IMV/RMV, and COV.
- Review and verify patient records, informed consent, case report forms, and source documents for accuracy and compliance.
- Manage query resolution and assist sites with the resolution of detected deficiencies.
- Develop protocols, study tools, monitoring plans, and document templates.
- Document and report site protocol deviations and violations.
- Review investigational drug accountability and safety event documentation.
- Provide mentoring, training, and co-monitoring to junior team members.
- Assist in the development of standard operating procedures.
MS Office