Executive (Study Monitor), Office of Research

1 week ago

Singapore National Skin Centre(S) Pte Ltd Full time

-Family Group: Administration

**Broad Function**

The Study Monitor is responsible for the oversight of clinical research for investigator initiated trials to ensure compliance with applicable regulatory standards, Human Biomedical Research Act (HBRA), Institutional Review Board (IRB) policies and hospital requirements. The Study Monitor will conduct site visits and remote monitoring in accordance with the study monitoring plan. He/She will also develop study monitoring plans as well as monitoring policies, work instructions and tools, etc. The Study Monitor is also responsible for identifying and escalating protocol deviations, noncompliance, and data discrepancies in order to ensure compliance with the study protocols and all applicable regulatory frameworks.

**Key Responsibilities and Duties**

**_Specific_**
- Perform on-site monitoring visits/remote monitoring for PI-initiated clinical trials in accordance with the study monitoring plan to ensure they are conducted, recorded and reported in accordance with the approved study protocol, applicable regulatory, IRB and hospital requirements.
- Develop a study monitoring plan for each study (e.g. percentage of records to be reviewed, frequency of review and plan for escalation of review).
- Communicate visit findings with site personnel and complete a written follow-up letter for distribution to the Principal Investigator and appropriate site personnel.
- Manage, coordinate and support study monitoring activities.
- Assist in initial and ongoing site personnel training as required.
- Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification review).
- Meet expected timelines for completion of monitoring activities and submission of written study monitoring reports.
- Provide guidance/advice in creating corrective and preventive action plans.
- Assist sites/study teams in audit readiness and preparation. Provide guidance/advice to study team in preparation for audits by reviewing all pertinent documentation and identifying gaps in required regulatory documents.
- Provide training to junior monitors.
- Perform regular review of study monitoring guidelines.

**_General_**
- Attend NHG Quarterly Sharing session on monitoring.
- Perform secretariat duties as assigned.
- Other Ad hoc duties as assigned by Manager/Clinical Director, Office of Research Development & Scholarship.

**Job Requirements**
- University Degree, preferably in Life science.
- At least 3 years of clinical trial experience with monitoring experience.
- Good Knowledge of International Conference of Harmonisation Guidelines of Good Clinical Practice (ICGGCP) guidelines, local regulations and clinical research process.
- Good verbal and written communication skills.
- Mature, resourceful, detailed-oriented, self-driven and team player.
- Energetic and self-motivated with good organizational and inter-personal skills.
- Ability to multi-task and exercise discretion with confidential information.
- Ability to manage multiple projects at a time and work independently.

  • Senior Executive/Assistant Manager

    2 days ago

    Singapore NATIONAL UNIVERSITY OF SINGAPORE Full time

    Interested applicants are invited to apply directly at the NUS Career Portal Your application will be processed only if you apply via the NUS Career Portal We regret that only shortlisted candidates will be notified. Job Description We are looking for an experienced clinical monitor to perform the study monitoring in ADVANcing Clinical Evidence in Infectious...

  • Research Executive

    5 days ago

    Singapore AXANTEUS RESEARCH PRIVATE LIMITED Full time

    1. Analysis and Report-writing - Designing studies and analysis strategies - Developing questionnaires and discussion guides - Statistical analysis - Charting - Analysis and Report-writing - Preparation of presentation materials and Presentations 2. Executing research projects: - Selection & management of research partners and other vendors -...

  • Research Executive

    1 day ago

    Singapore AXANTEUS RESEARCH PRIVATE LIMITED Full time

    **ROLES AND RESPONSIBILITIES** **1. Analysis and Report-writing** 1.1 Designing studies and analysis strategies 1.2 Developing questionnaires and discussion guides 1.3. Statistical analysis 1.4. Charting 1.5. Analysis and Report-writing 1.6. Preparation of presentation materials and Presentations **2. Executing research projects**: 2.1. Selection &...

  • Senior Executive, Graduate Studies

    3 days ago

    Singapore NTU (Nanyang Technology University- Main Office-HR) Full time

    The School of Chemistry, Chemical Engineering and Biotechnology is seeking to hire a Senior Executive to provide support to the Graduate Studies team. The incumbent will be supporting the school to effectively manage the graduate studies and research processes. **Admissions** - Prepare interview logistics and schedule interviews for shortlisted applicants -...

  • Research Analyst

    1 week ago

    Singapore ASEAN +3 Macroeconomic Research Office (AMRO) Full time

    J - Posted by Jessie Tan- Recruiter The ASEAN+3 Macroeconomic Research Office (AMRO) has vacancies for Research Analyst / Research Assistant in the **Regional Surveillance Group** and **Financial Surveillance Group**. **Responsibilities**: - Contribute to the preparation of AMRO studies and reports by providing and analyzing relevant data and statistics...

  • Business Development Executive

    3 days ago

    Singapore STUDY GENIE Full time

    **THIS IS A FULLY REMOTE POSITION** **THIS IS A COMMISSION BASED ROLE Study Genie, a start up tuition agency based in Singapore, is seeking a dynamic and results-oriented Business Development Manager to join our growing team. As a Business Development Manager, you will play a key role in driving the growth and expansion of Study Genie's...

  • Research Officer/ Senior Research Officer

    1 week ago

    Singapore Consortium for Clinical Research and Innovation Singapore Full time

    **Research Officer / Senior Research Officer - Tumour Organoid Research (STCC)** Overview The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore and establish important capabilities for a future-ready...

  • Research Officer, Human Development, Sics

    1 day ago

    Singapore A*STAR Agency for Science, Technology and Research Full time

    **Job Description**: - Assist in conducting the analyses of multidimensional, longitudinal data. - Assist in literature review and manuscript writing - Present research findings both orally and in written form. - Interface and facilitate interactions with multi-disciplinary researchers, data management, statistics, and project management teams. -...

  • Executive, Clinical Research

    1 week ago

    Singapore Tan Tock Seng Hospital Full time

    -Family Group: Administration As an Executive, you will provide administrative and operational support to all activities related to CRIO's services in the aspects of research studies monitoring & compliance as well as educational initiatives to promote research culture. This includes: - Plan, arrange and conduct monitoring visits for assigned research...

  • Research Executive

    5 days ago

    Singapore Blackbox Research Pte Ltd Full time

    Blackbox provides clients with decision science solutions, offering consumer, business, and community-wide perspectives on contemporary problems and challenges. We monitor emerging trends both regionally and globally to signal potential changes of significance before they occur. For over 20 years we have gathered data, constructed advanced analytical...