NINR Study/Protocol Monitor

Work with the team’s Research Nurse Specialist and Principal Investigator to lead, coordinate and conduct a site initiation visit for an observational research study. Verify that all study related documents such as the regulatory binder, investigator trainings, case report forms, screening and enrollment logs, check lists, flow sheets, etc. are completed prior to enrollment of 1st participant. Verify that all items on SIV checklist have been completed/addressed prior to the enrollment of the 1st participant.

Verify that all investigators/team members have signed the delegation log. Assure that the team has quality assurance and quality control measures in place . Verify that database for data collection (CTDB/CTSS) has been set up and is ready for data entry by the study team and/or research participants. Advise team of any issues/problems that need to be addressed prior to study launch.

Interim Monitoring Visits (IMV): Work with study research nurse, principal investigator and/or designee to obtain necessary study and regulatory documentation required for monitoring of study. Work with laboratory point of contact (POC) to obtain access to records and storage of study lab samples. Verify that all study team members are up to date with required research training, certifications, CVs, and licenses.

Complete a monitoring visit log, monitoring checklist/report, and action item log for each study that is monitored. Submit the completed monitoring visit log, monitoring checklist/report, and action item log to the Principal Investigator and NINR Clinical Director for each study that is monitored.