Shameema Ismail

• At the Wits RHI Research Centre Lab I was involved with different SAHPRA approved clinical trial studies under the directorship of Professor Helen Rees as well as with studies from sponsors such as MERCK and Gilead
• Testing based around HIV and STI's

My duties included but not limited to:

• Management of staff
• Stock control
• QA/QC and GCLP Compliance
• Reporting to management and staff
• Team meetings and presentations
• Validations

• Analyzers Cobas 8000,
• Serology
• QPE

• Instruments AU480
• Cobas E41

• Instruments: Roche Cobas 6000: Chemistry XN 1000: Haematology, Previously LH750,Gene Xpert, Architect Serology
• This is a laboratory dealing with clinical trial samples
• At CLS I was employed as a senior Biomedical Technologist

My duties included:

• Maintenance, calibration and troubleshooting of lab equipment in accordance with GLP & GCLP
• Preparation, analysis and interpretation of IQC and EQA samples
• Monthly IQC trend analysis monitoring
• Documentation of corrective actions where applicable
• Analyzing patient samples for research in clinical trials
• Reporting abnormal results to study coordinators and Doctors
• Running samples for validation
• Manual testing: Blood groups, RPR, TPHA, Urine microscopy
• I was required to file and retrieve paperwork
• I dealt with data clarification as well as doctors and site queries
• Stock management
• Quality control, Levy Jennings
• Assisted with audits
• Quality assurance
• Ensuring timely service and calibration of instruments
• Pipette and timer verifications
• Training of Technologists
• Performing internal audits

• Settting up of the PCR Lab
• Analysers Cobas 6800 and CAP/CTM
• Validations
• Implementation of new testing procedures

• To project manage and coordinate the activities of the IAVI program according to good clinical laboratory practice standards and according to the sponsor requirements (study protocols)

Job Description

• Client interaction and negotiation
• To operate in a pressurized environment
• Developing of quotations and budgets as required
• Generating of progress reports, expense reports and an External Quality Assurance report every quarter for senior management and the international sponsor
• Accumulation of data and trends were noted and indicated to the sponsor
• Allocation of activities to be undertaken, ensuring that tasks were completed as stipulated in the SOW (Scope of Work) within specified time frames
• Initiated meetings with sites and the sponsor to discuss activities, provide updates, to discuss and resolve issues
• Site monitoring and auditing
• Developing and review of the SOW
• EQA Enrollment and monitoring of the African Clinical Research Centers,12 in total
• Site assessments and audits in Africa with reports being sent to the international sponsor Namely, Uganda, Rwanda, Zambia and Kenya.

• Instruments:
• Integra 400+
• Sysmex x1000i
• In charge of EQA
• MOnthly Levy Jennings
• Training of technologists
• Technologist rosters
• Maintaining of files
• Locum technologist at Lancet Houghton Lab »Associations

• Logging and processing of insurance blood samples
• Instruments:
• Haematology – Pentra 80
• Chemistry, Immunology - Integra 400+
• Cobas 6000
• Vitros ECI

• Laboratories in Lenmed Clinic Lenasia, Clinpath qualified and worked under no supervision
• The instruments that I operated at Lenmed Clinic:
• Cell Dyn - Haematology
• Integra 400 – Chemistry
• At the Daxina Clinic:
• ACT 5 – Haematology
• Integra 400 – Chemistry
• At Garden City Clinic:
• LH 500 – Haematology
• Integra 400 – Chemistry
• TEG – Thromboplastin

• Familiar with maintenance and calibration of machines:
• COULTER – Haematology
• KONELAB – Chemistries
• ELECSYS – Endocrinology
• Prepared various reagents and stains in the lab
• Preparing of buffers
• Agglutinating testing
• Conducted the following tests:
• FBC + DIFF
• Malaria Screens
• Troponin T
• Serology- BHCG, ANF, RF, CRP, PI, PTT

• Trained in phlebotomy
• Preparing of stains and buffers
• Agglutinating testing
• Familiar with maintenance and calibration of machines:
• CELL DYAN – haematology
• ALCYON – Chemistries
• MCS procedures for various specimens
• Mycobacterium screening
• Manual PI and PTT
• Entering and authorizing of results
• Checking FBC diff counts manually
• Stock taking
• Trained in phlebotomy

General admin work:

• Answering of telephone calls
• Logging of specimens
• Following up payment of accounts
• After hours standby duty
• House calls