Quality Control Officer

2 weeks ago

Mowbray, South Africa University of Cape Town Lung Institute Full time

**Minimum Requirements**:

- Bachelor of Science Degree or Degree in Health Sciences
- 2 years relevant clinical trial experience
- Experience in quality control (within a research environment) is advantageous
- Documentation of adequate clinical research associate training
- Valid GCP (good clinical practice) certificate
- 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 CRF’s (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 Site’s 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.

**Additional Information**:

- The University of Cape Town Lung Institute is committed to equity in our employment practices and reserves the right not to appoint._

**Please Note: This Position is not on UCT Conditions of Service.**

Application Deadline: 2024/03/22

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