Executive / Senior Executive (Project Coordinator), Cancer Clinical Trials & IMU, STCC

Overview

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven 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)
• SIngapore Medical FOundation AI model (SIMFONI)
   

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!

The Singapore Translational Cancer Consortium (STCC) aims to strengthen the overall impact of cancer research and translation in Singapore by bringing together key basic, clinical and translational teams on joint platforms to actively establish and implement collaborative cancer programmes. STCC is part of the Consortium for Clinical Research and Innovation Singapore (CRIS) umbrella of research-related business entities and is supported by the National Research Foundation, Singapore (NRF) and the Singapore Ministry of Health through the National Medical Research Council (NMRC) Office, MOH Holdings Pte Ltd.

STCC; a nationally coordinated consortium to synergise cancer research capabilities in Singapore, brings together unmatched basic, clinical, and translational talent in Singapore to create globally significant peaks of excellence in selected Asian cancers.

STCC's five joint platforms – Cancer Clinical Trials and Investigational Medicine Units, Cancer Databases and Tissue Banks, Translational Research Integration and Support, Business Intelligence and Development, and Impact and Population Health – provide an enabling research and innovation environment driven to foster translational research and meaningful outcomes for society.

Through collaborative relationships with our partner institutions [comprising of National Cancer Centre Singapore (NCCS), National University Cancer Institute, Singapore (NCIS), National University Hospital (NUH), National University of Singapore (NUS) and Tan Tock Seng Hospital (TTSH)],  and by capitalizing on the strengths of industry and academia, STCC is uniquely poised to develop initiatives that are aligned with Singapore's goals in value-based healthcare innovation and economic value creation.

About the Role

The Project Coordinator (Clinical Trials) will be responsible for the duties and responsibilities listed below:

Primary Responsibilities and Duties

• Assist to draft and collect the study documents required for dossier submission to Institutional Review Board (IRB) and to the Health Sciences Authority (HSA).
• Track regulatory and ethics submissions, approvals and renewal timeline, submission and acknowledgement of adverse events and protocol deviations to ethics committees and regulatory authorities.
• Assist with feasibility assessments.
• Assist with review and execution of non-disclosure agreements, clinical trial agreements and research collaboration agreements with pharmaceutical/biotech companies, participating sites and vendors.
• Maintain and update feasibility tracker (list of feasibility requests) and database (frequently asked questions and answers repository).
• Assist to draft the site budgets and liaise with pharmaceutical/biotech companies and sites.
• Manage user access and issues for randomization system and clinical database.
• Assist with the creation of case report form and set up of database for assigned clinical trials.
• Liaise with the data manager, study monitor and the sites on the progress for data entry and cleaning.
• Set up, maintain and routinely review the electronic and hardcopy trial master file for accuracy, timeliness and completeness.
• Coordinate the distribution of SUSAR reports from the pharmaceutical/biotech companies to the sites for regulatory and ethics submission.
• Coordinate the logistics of laboratory activities between the central laboratories and the sites, track the biological samples sent to central laboratory and stored at all sites.
• Coordinate the procurement, purchasing and delivery of clinical trial services and investigational products, shipments of consumables and samples
• Monitor the investigational product inventories and activities according to trial SOPs at the site pharmacy
• Liaise with stakeholders (sites, CROs and vendors) to track/manage invoicing and payment matters.
• Update and maintain internal databases and tracking systems with project specific information.
• Coordinate and prepare materials and meeting minutes for trial meetings with internal and external stakeholders.
• Prepare study status updates and trackers/reports to management and sponsoring pharmaceutical companies.
• Coordinate and support STCC tumour groups related activities which include preparation of documents and facilitation of meetings.
• Assist in the review of the clinical trial protocol and study-related documents such as pharmacy manual, laboratory manual, drug request forms, SAE forms, study file templates, monitoring visit templates, etc.

What we are looking for 

Qualification

• Minimum Bachelor’s degree in life sciences, nursing, pharmacy, medical science or equivalent preferred.

Experience

• At least 1 year of experience in clinical research in a Pharmaceutical Company, or CRO.
• Possess knowledge of Good Clinical Practice (GCP), clinical trial monitoring, drug development process, regulatory requirements and basic knowledge of project management and medical terminology.

Skills

• Proficient in Microsoft Office e.g. PowerPoint, Word and Excel
• Meticulous with an attention for details.
• Good interpersonal and communication skills
• Flexibility and ability to multi-task and meet deadlines.

What you need to know

Successful candidate will be offered a 2-year renewable contract. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below:

CRIS – https://www.cris.sg
SCRI – https://www.scri.edu.sg
NHIC – https://www.nhic.sg
ACTRIS – https://www.actris.sg
PRECISE – https://www.npm.sg
STCC – https://www.stcc.sg
CADENCE – https://www.cadence-cvd.sg
SIMFONI - https://www.cris.sg/singapore-medical-foundation-ai-model-simfoni