Coordinates investigator/ site feasibility and identification process, as well as study startup.
Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
Manages Monitors in the query resolution process, including Central Monitoring observations.
Coordinates safety information flow and protocol/process deviation reporting.
Performs clinical supplies management with vendors on a country and regional level.
Ensures study-specific and corporate tracking systems are updated in a timely manner.
Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Coordinates planning of supervised monitoring visits and conducts the visits.
Manages the project team in site contracting and payments.
Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
Oversees project team in CAPA development and implementation.
Coordinates project team in process deviations review, management and reporting.
Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
Delivers trainings and presentations at Investigator Meetings.
Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
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