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