Clinical Research Coordinator, Neonatology (Contract)

• Provide research support service for clinical trials/research in accordance to ICH-GCP and protocol requirements • Independently responsible for administration of clinical trials as assigned by Principal Investigator (PI) at his/her professional discretion • Provide preliminary evaluation of site capabilities and potential challenges • Provide approved source document(s) and research data to the sponsor • Assist the sponsor or PI in the submission process for CIRB &/or HSA • Prepare and initiate meetings for investigator-initiated and less complex sponsor clinical trials. • Set up and maintain investigator site file(s) in accordance to SG-GCP • Ensure relevant approved documents are in place prior to and during the trial • Handle less complex commercial or IITs including overseeing recruitment of subjects • Manage/assist all subject-related issues and report all SAEs & SUSARs • Ensure full accountability of study equipment and investigational products during monitoring and study close-out • Ensure prompt and proper shipment of research samples to sponsor-appointed laboratories in compliance to BATA and IATA regulations • Complete CRF and research data promptly • Develop study specific source documents/CRFs • Assist to resolve data queries and discrepencie • Assist in quality control and prepare for quality assurance • Involve in site-close up activities and archive study site files, source documents and case notes • Ensure accuracy and monitor expenses in accordance with approved budgets • Provide instructions to Finance to issue invoices and handle communications between PI and sponsor companies • Handle communications between PI and sponsor companies • Attend investigator meeting and start-up meeting for trials Requirements: • Degree in Life Sciences/Pharmacy and any other relevant disciplines (Fresh graduate) • Diploma in Life Sciences/Pharmaceutical Science/CT Mgmt • Diploma/Adv Diploma/Degree in Nursing • Min 6 yrs CRC/relevant exp (Diploma holder) and demonstrated competency • Fluent in written and spoken English and a 2nd language/dialect • Intermediate computer skills (MS Office, Word and Excel) • People-management skill, strong team-player