Quality Assurance Manager - Stellenbosch, South Africa - Stellenbosch University DescriptionDuties/Pligte- Verskaf ondersteuning en opleiding in die bevordering en assessering van voldoening aan Goeie Kliniese Praktyk (GCP) regulasies, riglyne en bedryfsprosedures;- Ontwikkel, bestuur en implementer 'n gehalteversekeringsplan;- Ontwikkel, versprei, bestuur en koördineer opleiding oor Standard Bedryfsprosedures soos vereis binne die eenheid, insluitend DAIDS SOP's;- Hulpverlening met al die voorbereidings van alle eksterne monitering en oudits (verskaf ondersteuning tydens en na oudits);- Moniteer alle deurlopende kliniese proewe gedurende hul duur binne die Eenheid, wat wel kliniese terreinmoniteringsbesoeke op 'n gereelde basis behels soos vereis (interne monitering);- Moniteer die voorleggings van eksterne veiligheidsverslae per studie;- Identifiseer tekortkominge en ontwikkel en hou toesig ooren oor die implementering van regstellende aksieplanne soos vereis;- Verskaf deurlopende opleiding aan personeel oor veiligheidsmonitering en verslagdoeningsvereistes, hantering van biologiese monsters en databestuursaktiwiteite;- Verseker dat regulatoriese dokumente op datum bly, bv., HSP, GCP, HPCSA, SAPC en SANC;- Hou lab dokumente op datum, insluitend Tegniese Protokol, SANAS, CV's, IATA en Verwysingsreekse.- Providing support and training in the promotion and assessment of compliance with Good Clinical Practice (GCP) regulations, guidelines, andoperating procedures;- Developing, managing and implementing a Quality Assurance Plan;- Developing, distributing, managing and coordinating training on Standard Operating Procedures as required within the Unit, including DAIDS SOP's;- Assisting with all the preparations of all external monitoring and audits (providing support during and after audits);- Monitoring all ongoing clinical trials throughout their duration within the Unit, which involves clinical site monitoring visits on a regular basis as required (internal monitoring);- Monitoring the submissions of external safety reports per study;- Identifying deficiencies and developing and overseeing implementation of corrective action plans as required;- Providing ongoing training to study staff on safety monitoring and reporting requirements, handling of biological specimens and data management activities;- Ensuring that regulatory documents are up to date, e.g., HSP, GCP, HPCSA, SAPC and SANC;- Keeping lab documents updated, including Technical Protocol, SANAS, CV's, IATA, and Reference Ranges.Job Requirements/Pos Vereistes- Toepaslike wetenskaplike / mediese / verpleging-graad;- Vyf jaar se navorsings ervaring binne 'n kliniese navorsingsomgewing is noodsaaklik;- Drie jaar gehalteversekering-ervaring binne 'n kliniese navorsings omgewing;- Drie jaar bestuurservaring binne 'n kliniese navorsingsomgewing;- Goeie kliniese praktyk-oudit ervaring, insluitend kliniese monitering/kliniese proewebestuur en terreinbestuur;- Die vermoë om aan probleme van matige tot diverse omvang te kan werk en om goeie oordeel uit te oefen binne gedefinieerde prosedures en beleide om toepaslike optrede te bepaal;- In staat en bereidwillig om as adviseur op te tree en 'n aktiewe rol te aanvaar soos vereis om doelwitte te bereik of probleme op te los;- Bly op hoogte met kennis van kliniese proefmetodologie, GCP, ICH, en ander plaaslike/internasionale regulatoriese riglyne en vereistes, deur bywoning van opleidingskursusse, literatuuroorsigte, ens.- Relevant scientific / medical / nursing degree;- Five years' research experience within a clinical research environment is essential;- Three years' quality assurance experience within a clinical research environment;- Three years' management experience within a clinical research environment;- Good Clinical Practice auditing experience, including clinical monitoring/clinical trials management and site management;- The ability to work on problems of moderate to diverse scope and to exercise good judgment within defined procedures and policies to determine appropriate action;- Able and willing to act as advisor and assume an active role as required to meet goals or resolve problems;- Remaining current in knowledge of clinical trial methodology, GCP, ICH, and other local/international regulatory guidelines and requirements, through attendance at training courses, literature reviews, etc.Recommendation/Aanbeveling- Geregistreerde lidmaatskap by die Suid-Afrikaanse Verpleegings Raad (SANC);- A goeie begrip van twee van Suid-Afrika se elf amptelike tale;- Eie betroubare voertuig;- 'n Geldige rybewys;- Bereidwilligheid en beskikbaarheid om na ure te werk.- Registered membership with the South African Nursing Council (SANC);- A good command of two of South Africa's 11 official languages;- Own reliable transport;- A valid driver's licence;- Willingness and availability to work after hours. #J-18808-Ljbffr
