The Junior Research Coordinator's purpose is to lead a team in the conduct of one or more research studies. The Junior 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.