Research Coordinator

 The Research Coordinator’s purpose is to lead a team in the conduct of one or more research studies. The Research Coordinator is accountable to the Principal Investigator (PI) and or Program Manager (PM) and is responsible for all aspects of research projects highlighted below.  
• Act as the primary contact for internal support departments and external stakeholders.
• Development and monitoring of study timelines.
• Provide coordination and direction in the development of data management methodologies for multiple studies; including key data management methods.
• Provide coordination and direction in the development of site management practices for multiple studies; including collection and maintenance of essential site documentation per ICH-GCP guidelines, management and preparation of regulatory and health authority documentation, research ethics board documents and study contact information.
• Engage in ongoing communication and coordinate regular meetings with key study specific stakeholders. 
• Prepare presentations for external and/or internal meetings. 
• Adhere to all related compliance, safety and monitoring. 
• Prepare all ethics and regulatory documents in accordance with the institution and regulatory and GCP guidelines.
• Coordinate communication with all internal and external collaborators.
• Coordinate training of study teams/centers on all aspects of clinical study procedures.
• Coordinate /perform site monitoring and site visits to confirm adherence to study protocol, procedures, ICH-GCP guidelines, local and national regulations and guidelines.
• Help develop research study budgets, in collaboration with PI’s and other collaborators. 
• Help administer multiple study and sub-study accounts.
• Negotiate budgets with vendors, sites and other collaborators. 
• Support Principal Investigator(s) in preparation of proposals, grant budgeting and writing.
• Manage day to day study finance and study budgeting.