Participant pre-screening, recruitment and scheduling
Complete protocol and trial system training
Maintenance of regulatory documents
Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study.
Conducting participant visits
Ability to perform basic lab and clinical procedures
Entering data in the EDC and resolving all queries
Updating and maintaining trial logs and participant charts
Conducting monitoring visits
Managing and reporting of AEs, SAEs, and deviations
Maintains adequate inventory of study supplies
Coordinates appropriate and timely payments to participants
Manages and maintains all regulatory information about the study including the protocol