• 
  Perform monitoring visits according to plan, document actions and follow up on action plans

• Site feasibility visits including analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies

• Train and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs)

• Train site staff in safety information handling and systems

• Know and meet all local and company requirements with respect to safety reporting

• Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team

• Identify potential risks and proactively take action to prevent or mitigate

• Collaborate with data management/logistics in resolving queries

• Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan

• Manage trial product requirements, including temperature deviations and training of site staff

• Motivate and build strong relations with site personnel to ensure the sponsor is their preferred clinical research partner

• Ensure collaboration with and deliverables from vendors locally, if applicable

• Collection and management of essential documents

• Support the site in filing and archiving trial documentation in the Investigator Trial

Master File (ITMF)

• Participation in Investigators meetings to ensure relations with sites as well as active presentation as applicable