Collect raw data from relevant testing laboratories for the verification, review, and archiving of patient and study data.
Check and verify laboratory results to ensure accurate and timely reporting to clients and study stakeholders.
Perform data capturing activities to maintain accurate and complete records.
Review test runs, calculations, results, and reference ranges to ensure the correct setup and execution of clinical studies.
Prepare source documentation and raw data for audits, ensuring records are readily available and compliant with quality requirements.
Support internal and external audit processes by collaborating with the Total Quality Management (TQM) team and auditors.
Build and maintain positive relationships with clients and stakeholders, promoting Ampath's professional reputation.
Archive study documentation and raw data to ensure secure, compliant, and efficient storage and retrieval of information.
Provide Additional Administrative Support
Assist with additional administrative tasks and ad hoc requests as required to support departmental objectives and ensure efficient workflow management.
What you'll bring
Qualifications:
Grade 12.
Advantageous
Good Clinical Practice (GCP), Good Laboratory Practice (GLP), or Good Clinical Laboratory Practice (GCLP) certification.
Medical Technician or Medical Technologist qualification.
Experience:
Required:
Minimum of 4 years' clinical trial or laboratory experience within a pathology environment, preferably supported by a medical technology background.
Knowledge & Skills:
Meticulous attention to detail with a strong commitment to data accuracy and quality.
Strong interpersonal and communication skills, with the ability to collaborate effectively with clients, auditors, laboratories, and internal teams.
Knowledge of Good Laboratory Practices and quality assurance processes.
Sound understanding of regulatory requirements and Good Clinical Practice (GCP) standards.
Strong analytical skills with the ability to identify trends, discrepancies, and inconsistencies in complex data sets.
Exceptional organisational and document management skills.
Ability to work independently while managing multiple priorities and deadlines.
High level of professionalism and integrity when handling sensitive information.
Exceptional discretion with sensitive information, maintaining strict confidentiality of records, study data, and stakeholder discussions at all times.