KEY RESPONSIBILITIES:
Data integrity and quality assurance
Jointly accountable with: Principal Investigator (PI) and Co-investigators.
Ensure accuracy, completeness, and validity of clinical data collected.
Maintain alignment between extracted data and approved study protocols.
Review and address data discrepancies or quality concerns.
Ensure database outputs are reliable for analysis and reporting.
Ethical and regulatory compliance
Jointly accountable with: Principal Investigator (PI) and Co-investigators.
Ensure compliance with approved ethics protocols.
Uphold Good Clinical Practice (GCP) standards.
Maintain patient confidentiality and secure handling of sensitive data.
Ensure proper documentation for audits and monitoring visits.
Clinical data interpretation and query resolution
Jointly accountable with: Relevant clinical consultants and Multi-disciplinary Team.
Clarify ambiguous or incomplete clinical documentation.
Verify missing or inconsistent information.
Ensure accurate interpretation of clinical scenarios within the scope of practice.
Maintain professional communication regarding data-related queries.
Patient eligibility and protocol adherence
Jointly accountable with: PI and Co-Investigators.
Confirm appropriate patient inclusion in accordance with study criteria.
Ensure adherence to approved data collection frameworks.
Escalate protocol deviations where identified.
Research database governance and security
Jointly accountable with: Data Manager.
Ensure appropriate use of REDCap systems.
Maintain secure data storage and controlled access.
Support system audits and data verification processes.
Minimum requirements
A bachelor's degree in Nursing or equivalent (NQF Level 7).