Senior / Clinical Research Coordinator

7 days ago

Singapore Consortium for Clinical Research and Innovation Singapore Full time

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 healthcare system. The Business Entities under CRIS include:

- Singapore Clinical Research Institute (SCRI)
- National Health Innovation Centre (NHIC)
- Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
- Precision Health Research, Singapore (PRECISE)
- Singapore Translational Cancer Consortium (STCC)
- Cardiovascular Disease National Collaborative Enterprise (CADENCE)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you

**SCRI**

The Singapore Clinical Research Institute (SCRI) is the national coordinating body (NCB) for clinical trials with a vision to establish Singapore as a regional thought leader in clinical research. This is accomplished through the deployment of innovative technologies and processes, and strategic coordination of ecosystem capabilities and infrastructure to achieve synergies that will enhance the clinical research ecosystem aimed towards a healthier community and better patient outcomes.

**JOB PURPOSE**

The Senior / Clinical Research Coordinator will be seconded to the public healthcare institution to support the early phase clinical trials by:

- Supporting the investigators in the conduct and implementation of clinical research / clinical trials.
- Providing administrative support to activities related to clinical research / clinical trial implementation.

**MAJOR DUTIES OR RESPONSIBILITIES**

Early Phase Clinical Trials (Pharmaceutical Sponsored and Investigator Initiated Study)

Support the research investigators in coordinating the clinical research activities from study start-up, screening and recruiting/enrolling patients till the study closure, which includes but not limited to:

- Develop and implement study workflow, documents, materials and tools in accordance to the research protocols
- Assist in liaising and preparation of the IRB and/or regulatory documents for submission
- Coordinate screening, recruitment, follow-up visits and study procedures in accordance to the research protocols, ICH-GCP and institution polices
- Perform specimen collection, processing, labelling, storage and dispatch (e.g. blood, urine, stool, tissues)
- Conduct vital signs monitoring and ECG recording
- Maintain the Investigator Site Files and ensuring all documentation / records are accurate, complete and up-to-date
- Manage the investigational product (device, drugs, pharmaceuticals) which includes proper storage, documentation, dispensing, accountability, and labelling of drugs in accordance to the ICH-GCP guidelines and regulatory requirements
- Ensure the laboratory and diagnostic reports are available and reviewed in a timely manner
- Perform serious adverse events reporting within the required timeframe
- Attend investigator’s meeting (local / overseas), site initiation meeting, periodic meeting and close-out meetings
- Prepare the necessary billing documents to sponsors and/or other relevant stakeholders
- Monitor the financial aspects of the research study and update the research investigator
- Assist the research investigator in responding to any audit findings and implement approved recommendations, where appropriate
- Any ad-hoc duties as assigned by supervisor

**ORGANISATION RELATIONSHIP**

**JOB REQUIREMENTS**

EDUCATION
- At least a bachelor degree in life sciences, health sciences, nursing, pharmacy and/or related disciplines

EXPERIENCE
- At least 3 years of clinical trial experiences is an advantage
- A team player with excellent communication and writing skills
- Strong organizational, time management and problem-solving skills
- Trained in ICH-GCP and venipuncture is an advantage

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