Job Description - Clinical Research Coordinator (1 yr contract) - GOVT/ENTRY LEVEL #HAO
Job summary Coordinate study start-up activities
Assist with informed consent process
Monitor the quality of research
Job seniority: entry level
Responsibilities • Coordinate study start-up activities, including assisting with feasibility reviews and furnishing of regulatory documents
• Plan, organize and coordinate the workflow of the study
• Development of materials and tools required for study start-up
• Coordinate all mandatory training requirements and documentation
• Assisting with informed consent process by providing information to and educating research subjects, data collection and surveys
• Coordinate all relevant subject visits, ensuring minimum deviation from schedule of visits
• Ensure projects can be completed within the time frame and facilitate smooth running of research projects
• Assist PI to ensure timely amendments to study documents when required
• Monitor the quality of research ensuring compliance with HBRA, GCP, ICH & NHG guidelines and standards
• Conduct monitoring visits including Remote Monitoring and Site Monitoring
• Assist with all external monitoring, audit and inspection visits
• Monitor the financial aspects of the assigned study and advise the stakeholders accordingly
• Work with PI and department to respond to any audit findings and implement approved recommendations
• Assist with study closure activities including archival and assisting with all audits/ inspections/ monitoring
• Ensuring proper closure of study with all ethics and regulatory authorities
• Ensuring proper archiving of all study records including medical records, study documents, investigator files, subject files etc
Requirements • Min Degree in Life Sciences or similar
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