BackgroundThe Clinical Laboratory Services CLS, is a division of the Wits Health Consortium WHC of the School Pathology. CLS-s main purpose is to support the teaching and research activities of the School of Pathology through the provision of laboratory services, diagnostic and research advice, and data management support in accordance with the standards of Good Clinical Laboratory Practice GCLP.
CLS is an accredited laboratory and has a comprehensive quality management plan to ensure adherence to GCLP and its accreditation standards ensuring the integrity of clinical laboratory for clinical trial study participant care.
CLS has achieved ongoing certifications for SANAS South African National Accreditation System ISO 15189 and GCLP Accreditation through the British Qualogy Group and is also inspected by the Division of AIDS DAIDS annually.
Main Purpose of the jobTo support the activities of the clinical trials and / or clinical projects manager according to good clinical laboratory practice, study protocols, standard operating procedures and working instructionsLocationBraamfontein, Key performance areasParticipates in study coordination and support project managers - : Provide support to project manager in coordination of the study Coordinate study activities i.
e. maintain patient lists for relevant studies, no outstanding results, checking study storage is correct, check temperature logs for shipments Liaising with referral labs and clinical sites to ensure requests for urgent testing are metStudy support and facilitation - : Attend regular project meetings with team members to discuss operational issues i.
e. progress, deliverables, etc. Support the project manager in monitoring projects progress and resources to ensure compliance and adherence to all study requirements Closing out of studies and archiving Assist project managers with study setup Maintain site complaints log for queries received at CLS Coordinate meeting minutesRequired minimum education and trainingGrade Desirable additional education, work experience, and personal abilitiesCertification in good clinical laboratory practice GCLP and good clinical practice GCPExperience in clinical trials will be an advantageMust have a working knowledge of Microsoft OfficeCommunicate effectively with management, clients and sponsorsMust be able to establish and maintain effective working relationships with all stakeholdersRequired minimum work experienceExperience in a laboratory or clinical trials environment