QC Junior Internal Monitor at Desmond Tutu Health Foundation

Minimum Requirements:

• Grade 12 with a tertiary qualification in a Health related field
• At least 2 years’ working experience in a Clinical/Research environment
• At least 2 years’ experience conducting internal monitoring/quality assurance/quality control
• Experience in using Databases e.g. Imedidata
• Intermediate knowledge of computer applications like Microsoft Word, Excel and Power Point
• Working Knowledge of procedural document such as Standard Operating Procedure (SOP), Study Specific Procedures (SSP) and Manual of Operational Procedures (MOP)
• In depth knowledge of Investigator Site File and Essential documents, requirements and management
• Strong written and verbal proficiency in English and other local languages
• Excellent ability to build interpersonal relationships and partnerships within a diverse community
• Strong problem-solving and decision-making abilities
• Ability to work under pressure and independently
• Attention to detail
• Excellent Planning and organization abilities

Advantageous:

• Current SA Good Clinical Practice (GCP) certificate
• Valid Driver’s License, with own car
• Previous experience in SAHPRA and Ethics submissions
• In depth understanding and knowledge of Regulatory (SAHPRA) and Ethics Guidelines

Responsibilities:

• Review of the source data against the entries in the study database eCRF to confirm accuracy (QC)
• Review the source data (SDV) against guidelines to confirm compliance to protocol, procedures, patient safety, data integrity, and SA GCP and Quality Management plan amongst others
• Log and review protocol deviations and suggest corrective and preventative actions
• Implementation of corrective and preventative actions within a reasonable time
• Follow the monitoring plan for the study, site and or DTHF
• Assist the site by providing input regarding development and implementation of a clinical quality management plan, in line with requirements by funders and regulators
• Assist the site with all regulatory submissions and approvals and manage the process with support from the QA manager (HQ DTHF)
• Review all the HREC and SHAPRA approvals and communication to ensure that all applicable approvals and notifications are in place
• Review the Investigator Site File for completeness and accuracy assisting the site to keep it up to date
• Write Monitoring Report after each visit and communicate findings to the PI and site staff for corrections
• Regularly feedback sessions with HQ QA Manager
• Review and report outstanding issues at the site, for example Serious Adverse Events (SAEs), adherence to protocol and data quality issues
• Verify study conduct in accordance with national and International Guidelines, site SOP’s, Study SSP’s and protocol
• Assist the sites with Audit preparations
• Prepare reports to DTHF/C QA Manager for review