Key Job Responsibilities
• Assist in the planning, execution and closure of clinical studies by collaborating with interdisciplinary teams.
• Develop study-specific documents, tools, presentations and processes for approval.
• Prepare ethics submissions and study documents such as protocols, patient information leaflets, informed consent forms and case report forms.
• Maintain Trial Master Files and Investigator Site Files for multiple studies.
• Present at investigator meetings and participate in site qualification, study initiation and study closure process.
• Manage medical device tracking and accountability.
• Create and maintain study databases, including data entry, review and validation of data to ensure integrity and compliance.
• Track and report study progress to stakeholders including patient screening, enrolment, data collection and adverse event documentation.
• Develop study reports and provide clinical reports for regulatory submissions.
• Conduct monitoring and site visits, preparing reports on site visits, data queries, adverse events and study deviations.
• Serve as a liaison to work with clinical sites, CROs, SMOs and other vendors/consultants.
• Stay up-to-date with applicable regulatory requirements and clinical literature.
• Ensure compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki and Data Protection Act.
• Perform other clinical duties as required.