Parow / Bellville
Overall Purpose of the Position:
The pre-analytical phase within clinical trials covers accurate collection, storage and of a shipping sample as per approved clinical study protocols and related guidance documents.
The pre-analytical supervisor provides high-end quality control over the pre-analytical phase to ensure collection of samples is suitable for analysis, provides effective solutions and recommendations in the pre-analytical phase of clinical trials and ensures continuous improvement through the implementation of a quality system, taking into account all technical and human resources aspects to deliver quality service.
Key Performance Areas (KPA’s) & Responsibilities includes, but not limited to:
- Review protocol and study manual (s) and support with pre-analytical study start up requirements
- Develop training material, standard operating procedures, policies and quality control systems needed for the pre-analytical phase
- Attend site initiation visits and assist with slide preparations and presentations
- Train staff and conduct competency testing
- Supervise the quality of the pre-analytical phase at all TASK locations g. scrutinizing and commenting on lab processing chart / lab manuals / manual of operating procedures, provide lists of materials /consumables needed, standardise sample collection procedures, sample handling, sample processing, QC checking: sample rooms, sample collection, centrifugation, aliquoting, documentation, storage, temperature excursions, shipments schedules, shipment documentation and preparation, query resolution and export permit tracking.
- Report on issues identified
- Provide effective solutions and recommendations, corrective actions and preventative measures
- Assist and support TASK in external and internal audits
- BSC / Biotechnology / Medical Technologist (Clinical Pathology)
- Valid Good Clinical Lab Practice (GCLP) certificate or willing to attend a GCLP course
- Valid Good Clinical Practice (GCP) certificate or willing to attend a GCP course
- Valid Driver’s Licence and own transport
- Must be prepared to travel between sites (Cape Town based)
Key Personal Inherent Characteristics
- Meticulous – attention to detail
- Excellent communication both verbal and written
- Self-starter – ability to work independently
- Problem solving
- Team player
- Effective time management
- Prioritizing workload
APPLICATIONS CLOSE: 22 August 2019
Please use the following reference when applying for this position: PAQS
If you have not heard from us within one month, please consider your application as unsuccessful.
Task Applied Science reserves the right to withdraw this advertisement and not fill the above mentioned vacancy at any stage during the recruitment process.