Study Coordinator, Clinical Trials Unit

at  Raffles Medical Group

Category:Professionals
Location:Singapore
Function:Ancillary and Support
Date Posted:Jul 1, 2024
The Executive of CTU works as a Clinical Research Coordinator to carry out clinical trial protocol procedures in accordance with the ethical principles, Singapore Good Clinical Practice guidelines, hospital policies and JCI requirements.

JOB REQUIREMENTS

• Diploma, Bachelor’s Degree, Post Graduate Diploma, Professional Degree, Life Science, Medicine, Nursing or equivalent.
• At least 1 year(s) of working experience in the related.

• Regulatory and ethical submission and communicating with the relevant authorities.
• Implementation of the clinical trial activities from study initiation to study close out.
• Clinical trial subject screening and recruitment, subject appointment scheduling, biological sampling, biological sample preparation and shipment, time management and study drug accountability.
• Gather quality data and ensure timely and accurate transcription of information from source documents to the case report forms.
• Record and reporting of Adverse Events and Serious Adverse Events to IRB and sponsor according to requirements.
• Ensure completion and accuracy of the essential documents and records according to regulatory requirements.
• Manage investigator site files and maintain study related documents.
• Interaction with external study monitors/auditors, answering data queries from sponsors or CROs.
• Inter-departmental communication and coordination for study related procedures.
• Ensure proper storage and usage of Clinical trial material (e.g. lab kits) received from sponsor.
• Promote a positive and engaging work environment. Maintain a good working relationship among medical personnel, patients and the public.
• Ensure hospital and CTU SOPs are followed closely, timely report of problems encountered during clinical trial process.