Minimum Requirements: Bachelor of Science Degree or Degree in Health Sciences (advantageous) 2 years relevant clinical trial experience Experience in quality control (within a research environment) would be preferrable Documentation of adequate clinical research associate training Valid GCP (good clinical practice) certificate (advantageous) Advanced computer skills (proficient in MS Office, especially MS Excel, internet browsers and medical databases) Excellent communication and interpersonal skills Detail-orientated, with strong organizational skills Proactive and able to work in a fast-paced environment Analytical and effective problem-solving skills Responsibilities include (but not limited to): Regulatory compliance and quality assurance for the research data produced in the unit Develop tools to be used by site staff and perform retrospective, objective, periodic, systematic reviews of trial-related activities at the site.
Oversee monitoring of source documentation and CRFs (Case Report Forms) as and when required and assess source data verification needs per study.
Monitoring validation of participant source files to ensure completeness and consistency of data Maintain appropriate documentation regarding monitoring findings.
Overseeing implementation of Sites Clinical Quality Management Plan and perform regular reviews.
Review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements and making recommendation for improvement as appropriate.
Review QC requirements and ensure that quality control documentation for a study meets requirements.
Ensure completeness, accuracy and consistency of the data to ensure quality standards expected for reporting to regulatory bodies.
Responsible for the quality control of research data collected in the unit Assist in raising source or CRF queries with relevant staff and review that these queries are resolved adequately.
Only shortlisted candidates will be contacted.
Should you not receive a response within 30 days of the closing date, please consider your application unsuccessful.
The University of Cape Town Lung Institute is committed to equity in our employment practices and reserves the right not to appoint.
The selection process will be guided by the Employment Equity Plan and Targets of the University of Cape Town Lung Institute (Pty) Ltd. *Please Note: This Position is not on UCT Conditions of Service.