Overview
To 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.
Job Responsibilities
A) Primary 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 Management
- Assist Investigators in the screening, recruitment, and follow-up visits of potential patients.
- Assist investigators in obtaining informed consent.
- Perform venepuncture and cannulation as required according to trial protocol.
- Schedule appointments for patients/subjects.
- Dispense 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 Administration
- Attend trial-related initiation, close-up and other trial related meetings.
- Plan, organize and co-ordinate trial study activities workflow.
- Ensure accurate documentation in source documents.
- Complete Case Report Forms (CRFs) in timely manner.
- Handle data entry and validation of study data.
- Process, label and dispatch specimens to the relevant laboratory as in the condition as specified in the trial protocol.
- Label and store specimens in the condition as specified in the trial protocol.
- Trace laboratory and diagnostic reports (if any).
- Assist the investigator(s) in adverse events / serious adverse events reporting.
- Maintain confidentiality on trial data.
- Maintain Investigator Site File and ensure that all study documents are complete and up-to-date.
4. Ethics and Regulatory Submission
- Assist 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).
B) Secondary Responsibilities and Duties (10%)
Perform administrative duties and ad-hoc projects as assigned by the supervisor.
Requirements
- Degree in Nursing/Life Science/Healthcare related courses or Diploma holder with relevant clinical research experience.
- Previous work experience in clinical research/nursing will be an advantage.
- Good written and communication skills. Ability to speak other languages and common dialects will be an added advantage.
- Possess strong interpersonal skills.
- Able to work meticulously, independently and to be a team player.
