- Facilitate and coordinate with investigator and site for EC submission and approval.
- Conduct site feasibility and qualification visits.
- Get trained on trial and documents.
- Prepare for kickoff
- meetings to train vendor representatives involved if outsourced
- activity for monitoring.
- Coordinate with investigator and sites for IM and assist PM in planning for IM
- Conduct SIVs, write SIV reports, and dispatch to sites
- Resolve queries and problems at sites and with vendors.
- Monitor sites, write monitoring visit reports and send timely monitoring followup
- letters to sites.
- Obtain updated weekly trackers from sites
- Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
- Coordinate with data management team and investigator/site team for timely DCF resolution.