Technical and Operational Specialist

**About the Company**:
TASK is a clinical research institute and social enterprise committed to developing, testing and progressing novelty medicines, vaccines and diagnostics in various medical therapeutic areas aimed at improving global health care. TASK performs clinical trials at various sites in Cape Town and George, South Africa.

TASK Laboratory is a bio-safety level 3 (BSL-3) lab, which performs testing for drug susceptible and drug resistant TB, using established diagnostic methods and new research platforms.

**Overall Purpose of the Position**:
To provide first class clinical tuberculosis laboratory services by performing technical procedures, laboratory maintenance, data management and administrative duties within the scope of activities provided by the TASK Laboratory for clinical drug trials.

**Key Performance Areas (KPAs) & Responsibilities include, but not limited to**:

- Assisting the Head of Laboratory in monitoring productivity and workload of functional areas; identifying peak and slack periods; and assisting in making operational or staffing adjustments
- (Overall responsibility for) maintaining and managing BSL 2/3 laboratory facilities
- Managing and assisting (as required) the addition of clinical trials parameters to the LIMS according to sponsor requirements by closely communicating with sponsor and sponsor/data team
- Approving LIMS software (DISA) and performing QC checks before roll out
- Assisting with TASK’s data management team on the LIMS to ensure that all clinical trial requirements are met for lab data reporting
- Coordinating data transfer agreements with sponsor data teams
- Assisting data management with transferring of laboratory datasets in accordance with data transfer agreement
- Implementing new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress
- Reviewing and reporting results and interacting with laboratory management on technical matters to maintain effective management of the data required for the efficient functioning and smooth running of the laboratory to meet clinical trial requirements
- Developing and implementing practical plans to perform troubleshooting and critically addressing and resolving clinical laboratory queries
- Managing lab equipment, updating asset register and scheduling equipment service
- Assisting the Head of Laboratory with overseeing and monitoring effective utilisation of resources, optimisation of stock levels and reduction of costs. Ensuring that there is adequate stock in the laboratory and no wastage
- Communicating promptly to the Head of Laboratory and Quality Manager any breach in operational matters and quality issues
- Assisting with providing reporting data where needed, including lab management reports
- Ensuring that all monitoring and data queries are responded to timeously
- Assisting and contributing to the implementation and maintenance of the quality systems that govern the laboratory and the service components of the laboratory to ensure compliance with the principles of Good Laboratory Practice (GLP) and fulfilment of SANAS accreditation requirements
- Liaising with clients to resolve service-related issues, maintaining a positive image of the organization, and promoting the service of the laboratory
- Reviewing and implementing changes to standard operating procedures to ensure the laboratory is constantly able to provide a high quality, cost effective and safe service
- Carrying out any other function relevant to the position as may be delegated by the Head of the Laboratory
**In addition to the above - mentioned duties, the following duties may also be required from time to time;**
- Performing specialist technique testing such as MIC (Minimum inhibitory concentration)
- Assisting with daily activities of supervisors to ensure that timeous reporting, verifying of results and meeting the expected turnaround times of clinical processes and escalating matters to the Head of Laboratory when the above is not met
- Assisting supervisors with drawing up of the weekly roster for staff rotation for the BSL-3 and BSL-2 laboratory ensuring that all workstations are covered. Ensuring that laboratory productivity is upheld by monitoring workload of functional areas
- Assisting with on-site training of laboratory technologists, laboratory technicians and laboratory assistants in clinical laboratory techniques, processes, and systems. Evaluating them for competency with documented proof
**Ideal Requirements**
- Relevant National Diploma or BSc degree in microbiology
- At least 3 years’ experience working in a TB microbiology laboratory
- Knowledge of DISA (LIMS)
**Key Personal Inherent Characteristics**
- Attention to detail
- Ability to work under pressure and manage deadlines
- Ability to understand the business and related industries
- Good communication skills
- Good leadership skills
- Ability