Clinical Research Coordinator, NUHCS (CTU)

National University Health System; Singapore; On-site; SGD 40,000 - 64,000; Full time

Job summary

National University Health System in Singapore is seeking a Clinical Research Coordinator to support investigators in conducting trials in accordance with ICH GCP, HBRA and hospital policies.

You will assist with screening, consent, venepuncture, scheduling, data entry, CRFs, and specimen handling, while maintaining regulatory and ethical standards and coordinating trial activities across teams.

Qualifications

• Degree in Life Science/Nursing/Healthcare related courses or Diploma holder with relevant clinical research experience.
• Able to work meticulously, independently and to be a team player.
• Possess strong interpersonal skills.
• Ability to speak other languages and common dialects will be an added advantage.
• Flexibility to work on weekends occasionally.

Responsibilities

• Assist Investigators in 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/participants
• 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.
• Attend trial-related initiation, close-up and other trial related meetings
• Plan, organize and co-ordinate trial study activities workflow
• 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
• 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)
• Perform administrative duties and ad-hoc projects as assigned by the supervisor.

Skills

Interpersonal skills

Team player

Attention to detail

Weekend availability

Communication skills

Education

Life Science degree

Nursing degree

Healthcare diploma

Job description

Roles and Responsibilities

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.

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.

• 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/participants
• 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.

Clinical Trial Administration

• Attend trial-related initiation, close-up and other trial related meetings
• Plan, organize and co-ordinate trial study activities workflow
• 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

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)

Secondary Responsibilities and Duties (10%)

• Perform administrative duties and ad-hoc projects as assigned by the supervisor.

Requirements

• Degree 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.
• Ability to speak other languages and common dialects will be an added advantage.
• Flexibility to work on weekends occasionally.