Description:
Main purpose of the job:To perform Quality Assurance duties in PHRU Matlosana in accordance with Good Clinical Practice (GCP) standards Ensure QA and QC activities are performed effectively across studies Where trends identified, coordinate relevant staff training Location:
Edendale Lay Ecumencial Center Clinic, Edendale, Pietermaritzburg Key performance areas:
Ensure a thorough understanding of the project protocol and the SSP manuals Attention to detail and accurate entry is critical Basic medical terminology and helpful for understanding case report forms (CRs) and clinical records Good communication skills for working with clinical staff and research coordination Participate in Project Team meetings as required and provide constructive feedback and support to other team members Maintain a positive and constructive partnership with study Investigators and other site staff through constructive feedback, provision of assistance and active problem solving To conduct Quality Control and Quality Assurance activities for the clinical trials, assist with regulatory communications and adherence, and train the site personnel in the protocol and its requirements Ensure all queries are attended to appropriately and in a timely manner Discuss QC trends with study team during team meetings To pay attention to trends in the QC findings and to conduct refresher training where necessary Ensure the defined protocol is always adhered to Ensure all required protocol parameters are always followed and recorded accurately Ensure study staff is always following study standard operating procedures Required minimum education and training:
Grade 12 Post Matric Qualification in Health Sciences, Information Technology or related field is an advantage Fluent in English and IsiZulu Valid drivers licence and able to drive a manual vehicle A recognized Quality Control Course (for clinical trials) Advantageous Human Subjection Protection Certificate will be advantageous TRREE (Training and Resources in Research Ethics Evaluation) will be advantageous Electronic data systems (e.g RedCap) and Excel ALCOA + Principles ABC of Quality Control Certificate and Good Clinical Practice Certificate (GCP) Required minimum work experience
1 - 2 year's experience in quality control procedures in clinical trials 1 - 2 year's
03 Jul 2025;
from:
gumtree.co.za