The Quality Control Officers will report to the QA Officer and will be responsible for ensuring that the data collection and filling work (both paper and electronic) is conducted as per the SR study protocol and GCP standards. S/he must be flexible and work within the existing structure, in a professional and ethical manner with competence, accountability and integrity.
Diploma in Nursing, Clinical Medicine or Medical Laboratory
At least two (2) year working experience in performing QA/QC in a busy clinical trial
Have a good working knowledge of GCP requirements for clinical trials.
Should have experience working with MS suite (MS Word, Excel and Powerpoint)
Licensed motorcycle rider is an added advantage.
Monitor study team compliance with required study procedures and GCP standards.
Assess and ensure subject safety throughout participation in trial.
Assist in monitoring and documenting adverse events.
Ensure that the chain of custody of the Study ICF and samples are well maintained.
Review all participant files for accuracy and ensure specific visit on CRF are completed as per GCP standards.
Perform QC review of all microscopy result forms.
Assist component leads to resolve QC queries and record discrepancies identified during reviews.
Accurately and timely report the problems requiring action from the study component lead, Regulatory Officer and the PI.
Ensure that the ICF is complete and according to GCP standards.
Performing quality control checks on source documents.
Writing and reviewing of study Standard Operating Procedures.
Developing of study source documents
Any other duties assigned by the Regulatory Officer.
: Diploma, Associate's degree
Required relevant work experience
: 2 years
English (Spoken: fluent | Written: fluent)
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