Clinical Research Coordinator, NUHCS (CTU)

OverviewTo assist investigators in conducting clinical trials and research according to study protocol, ICH Good Clinical Practice (ICH GCP), Singapore Human Biomedical Research Act (HBRA) and other applicable regulatory and ethical requirements as well as hospital policies.Roles and ResponsibilitiesPrimary Responsibilities and Duties (90%)1. Compliance with the ICH GCP, HBRA and other applicable regulatory and ethical requirements as well as hospital policies if applicable.2. Patient ManagementAssist Investigators in the screening, recruitment, and follow-up visits of potential patientsAssist Investigators in obtaining informed consentPerform venepuncture and cannulation as required according to trial protocolSchedule appointments for patients/participantsDispense study drugs, perform drug reconstitution (if applicable) and maintain drug accountability log under the supervision of investigator.Perform other protocol specific procedures such as interviewing subjects, taking vital signs, ECG and etc.3. Clinical Trial AdministrationAttend trial-related initiation, close-up and other trial related meetingsPlan, organize and co-ordinate trial study activities workflowEnsure accurate documentation in source documentsComplete Case Report Forms (CRFs) in timely mannerHandle data entry and validation of study dataProcess, Label and dispatch specimens to the relevant laboratory as in the condition as specified in the trial protocolLabel and store specimens in the condition as specified in the trial protocolTrace laboratory and diagnostic reports (if any)Assist the investigator(s) in adverse events / serious adverse events reportingMaintain confidentiality on trial dataMaintain Investigator Site File and ensure that all study documents are complete and up-to-date4. Ethics and Regulatory SubmissionAssist the Investigator in applying to the Institutional Review Board (IRB) for ethics review and to the Health Sciences Authority (HSA) for clinical trial authorization / clinical research material (if required)Assist the Investigator in submission of status reports / non-compliance reports (if any) to IRB and HSA (if applicable)Secondary Responsibilities and Duties (10%)Perform administrative duties and ad-hoc projects as assigned by the supervisor.RequirementsDegree in Life Science/Nursing/Healthcare related courses or Diploma holder with relevant clinical research experience. Previous work experience in clinical research will be an advantage.Able to work meticulously, independently and to be a team player.Possess strong interpersonal skills.Good written skills. Ability to speak other languages and common dialects will be an added advantage.Flexibility to work on weekends occasionally.