Job Description:
To assist investigators in conducting clinical trials and research according to study protocol, International Conference on Harmonization Guideline for Good Clinical Practice E6 (ICH GCP E6) and other applicable regulatory and ethical requirements as well as IMU Standard Operating Procedures (SOPs) and hospital policies.
Primary Responsibilities and Duties:
· Assist in the conduct of Clinical Study/Research and be incompliance with the ICH GCP E6 and other applicable regulatory and ethical requirements as well as IMU SOPs and hospital policies if applicable
· Assist the Principal Investigator in applying to the NHG Domain Specific Review Board (DSRB) or Institutional Review Board (IRB) for ethics review and to the Health Sciences Authority (HSA) for Clinical Trial Authorization (CTA)/ Clinical Trial Certificate (CTC)/Clinical Trial Notification (CTN)/Clinical Research Material (CRM) (if required)
· Liaise with the stakeholders (e.g. NUH Finance, lab, kitchen, etc) and coordinate related finances and logistics
· Attend trial-related initiation, close-up and other trial related meetings
· Plan, organise and co-ordinate trial study activities workflow
· Complete Case Report Forms (CRFs)
· Handle data entry and validation of study data
· Label and dispatch specimens to the relevant laboratory as in the condition as specified in the trial protocol/lab manual
· Label and store specimens in the condition as specified in the trial protocol/lab manual
· Trace laboratory and diagnostic reports (if any)
· Assist the investigator(s) in adverse events / serious adverse events reporting
· Maintain drug accountability logs
· Document and tabulate financial payments received and / or made to support the study
· Return all trial materials to sponsor company at the end of the study
· Maintain confidentiality on trial data
· Maintain Investigator Site File and ensure that all study documents are complete and up to date.
· Assist investigators in the screening and recruitment of potential patients/healthy volunteers as according to trial protocol
· Assist investigators in obtaining informed consent
· Perform venepuncture and cannulation as required according to trial protocol
· Assist in the preparation/administration of medication intravenously (IVM)
· Maintain and update screening log & enrollment logs
· Schedule appointments for patients/subjects
· Ensure patients’/subjects’ compliance to trial medication (if any)
· Maintain confidentiality on patients’/subjects’ data
· Perform Code Blue Emergency procedures* on collapsed subjects/patients
· Provide regular trial updates to investigators/ sponsor companies and IMU Manager(s) for trial-related issues
Perform administrative duties as assigned by the Managers/Director
Requirements:
· Qualification: Diploma/degree in life sciences, diploma/degree in nursing, or equivalent preferred
· Minimum 2 years of clinical research experience preferred
· Good understanding of ICH GCP E6
· Motivated, self-driven and able to work independently and meticulously
· Good written and communication skills. Ability to speak other languages and common dialects will be an added advantage
· Possess strong interpersonal skills
· Flexibility to work on weekends and night shifts occasionally
Team player
