Job Purpose 1) To assist in the Department’s (Haematology non-therapeutic) lymphoma disease research efforts 2) To assist in other duties as needed by the Haematology Division
Duties and Responsibilities
Primary Responsibilities and Duties (80%)
Ethics, Regulatory and Essential Documents:
• Ensure that the necessary Ethics and Regulatory approvals (if applicable) are obtained before the initiation of the study.
• If required, coordinate the submission of study agreement contract to the Research Office (RO). Ensure that the agreement is signed by the sponsor, Principal investigator(s) and RO prior to the start of patient enrollment.
• Assist the Principal Investigator (PI) in the initiation of the study by preparing for the Site Initiation Meeting and obtaining the signature of the study team on the Delegation of Responsibility and Signature Log.
• File all relevant correspondences.
• Ensure the Investigator files and all the essential documents are properly maintained.
• Review and understand all assigned protocols.
• Initiate and maintain screening, enrollment and subject identification logs. Monitor recruitment progress and update PI and study team regularly.
• Where applicable, screen for potential study subjects, check potential subjects with the attending doctor and assist at the screening visit.
Informed Consent Process:
• Assist the investigator in the informed consent process. Obtain signatures and dates from the subject and/or witness. Provide a signed copy to the subject.
• Document in the case notes that informed consent has been obtained before any study procedures.
• File original signed informed consent in the designated folder.
• Assist the investigator in checking the results to ensure subject's eligibility.
• Ensure that adequate clinical supplies and logistics are in place throughout the study.
• Ensure that biological samples are properly collected at the stipulated time points, accurately labeled and processed.
• Responsible for the transportation to and storage of the samples at the correct labs/collaborators.
• Maintain the biological sample logs
Case Report Forms (CRFs)/Databases:
• Extract information from medical records for electronic and/or hardcopy databases/CRFs
• Complete CRFs promptly and accurately. Obtain the investigator's input whenever necessary.
• Respond to data queries regarding CRFs corrections, revisions and clarifications and ensures resolution of data queries.
• Oversee scheduling and conduct of monitoring and audit.
• Collaborate with investigators and collaborators in providing accurate data for analysis
• Assist PI in collating data for analysis pertinent to presentations and publications.
• Work closely with the investigators in ensuring data confidentiality and credibility
Secondary Responsibilities and Duties (20%)
• Assist the respective disease head haematologists in organizing events, patient booklets, gatherings for patients and caregivers
• Point of liaison for compassionate drug programs
• Assist the haematologists in coordination of the Tumour Board
• Assist the doctors in getting the Tumour Board forms ready for discussion and upload
• Ensure the logistical smooth running of the meeting
Enrolled Nurse or Degree in biomedical/health science or related field
- Phlebotomy experience preferred
- 1-2 years of clinical research experience preferred
- Proficient in written and spoken English and/or Mandarin/Malay
- Good interpersonal and communication skills with patients and colleagues
- Good work attitude, organized, able to multi-task, work independently and perform well under pressure
- Computer proficiency is essential – MS Word, Powerpoint and Excel