To conduct and oversee the implementation of clinical research and trials on cognitive impairment according to study protocol, SG-GCP, hospital policies, and applicable regulatory and ethics requirements.
Roles and Responsibilities
- Compliance with the SGGCP and other applicable regulatory and ethical requirements as well as 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 certificates (if required)
- Coordinate and manage all aspects of clinical research and trials from site initiation, subject recruitment, data collection, to study close-out.
- Identify, recruit, and screen potential study subjects based on protocol criteria.
- Administer informed consent to enrolled subjects.
- Schedule study visits and procedures, providing reminders to ensure subject retention.
- Ensure proper collection, management and storage of research data and biological samples.
- Set up and maintain study investigator files, including records of consent taken and blood collection.
- Maintain and update screening log & enrolment logs.
- Ensure patients/subjects compliance to trial medication (if any).
- Assess and report adverse events and maintain safety documentation.
- Assist the Principal Investigator in adverse events / serious adverse events reporting.
- Act as the main point contact liaison for study sponsors, contract research organizations (CROs), and study team members.
- Assist Principal Investigator with preparation of documents for ethics submissions and renewals and to the to the Health Sciences Authority (HSA) for clinical trial certificates (if required).
- Work cross-functionally with medical, research, and operations teams involved in the study.
- Liaise with the relevant departments for logistic and finances-related matters.
- Prepare necessary documentation for audit purposes.
- Complete Case Report Forms (CRFs).
- Provide care coordination and supporting clinicians for memory clinic service.
- Assist investigators in the screening and recruitment of potential patients/healthy volunteers as according to trial protocol.
- Assist investigators in obtaining informed consent.
- Perform delegated procedures as required according to trial/study protocol.
- 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.
- Administer the study drug with the route of administration required by the study protocol (i.e oral, subcutaneous injection, intravenous infusion & etc).
- Provide regular trial updates to investigators/ sponsor companies and manager(s) for trial-related issues
- Perform administrative duties and ad-hoc project as assigned by the Director/Manager
- Provide care coordination and supporting clinicians for memory clinic service.
Requirements
- Fast learner who adapts quickly and takes initiative to solve problems.
- Responsible, able to work independently and collaborate as part of a team player.
- Demonstrates leadership, accountability, and ownership of tasks.
- Excellent interpersonal and organizational skills.
- Able to manage multiple projects with excellent project management skills and to thrive under pressure in a fast-paced environment.
- Good written and communication skills.
- Proficient in other languages (Mandarin/Malay/Tamil) and/or Chinese dialects will be an added advantage due to the patient demographics of an elderly population.
- Meticulous attention to detail and documentation practices.
- Familiar with Good Clinical Practice (GCP) guidelines and the Human Biomedical Research Act (HBRA).
