Clinical Research Coordinator (Dept of Colorectal Surgery) (Contract)
2 months ago
The Clinical Research Coordinator provides research support service for clinical research, in accordance to the applicable regulatory, Good Clinical P.....
The Clinical Research Coordinator provides research support service for clinical research, in accordance to the applicable regulatory, Good Clinical Practice and protocol requirements. He/she works closely with the Principal Investigator (PI), members of the department, study sponsors and monitors, etc. to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
He/she will ensure smooth and efficient day-to-day logistics support for research studies, and assists in study quality control activities such as internal monitoring, and prepares for auditing/ inspection.
Responsibilities:
Manages different phases of clinical research study independently. Acts as liaison between subjects and members of the research team to facilitate and coordinate the daily clinical study activities including subject recruitment and questionnaire administration
Participates in the evaluating of the study proposals and protocols. Comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
Assists PI in designing and development of study recruitment advertisement, study specific source documents/ Case Report Forms and other required documents pertaining to the protocol
Assists PI in the study submission to IRB or HSA. Oversees all study subject-related issues, timely report all safety events according to sponsor, IRB and regulatory authorities requirements.
Assists in budget preparation and facilitates project agreement
Develops and maintains study payment tracker, prepares study participants payment reimbursement.
Verify study account expenses, and prepares study billing requisition for finance department to process, and follow up with stakeholders on the payment.
Assist in preparing grant progress reports, final reports, extension applications, and variation requests
Extract and trawl relevant clinical data from electronic medical records and clinical information systems
Collect, record, and manage study data
Ensure data accuracy, completeness, and timely entry into electronic data capture systems and case report forms
Provides study protocol specific training to delegated staff with supervision of PI
Assists in Quality Control & Quality Assurance activities, such as department study internal monitoring and department audit/ inspection.
Ad-hoc research related activities as directed by the supervisor
Job requirements:
Bachelor Degree in Nursing/ Medical Technology / Health Science / Life Science / Pharmacy
Interest in scientific research and willing to engage in various aspects of the research processes
Proficient computer knowledge (MS Office – Word, Excel, PowerPoint)
Data science background would be advantageous
Good interpersonal skills
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