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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/or Clinical Director (CD) 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. 


Qualifications

• Bachelor's degree in a relevant field of study.
• Minimum 3 years previous experience in multi-center research studies/clinical trials or other research projects.
• Experience with the management of large clinical research studies and or databases.
• Working knowledge of ICH-GCP Guidelines and international research requirements.
• Highly efficient computer skills, extensive experience with the Microsoft office suite.
• Supervisory experience and team coordination.


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