Essential Requirements:Bachelor of Science Degree or Degree in Health Sciences (advantageous) OR Grade 12 / Senior Certificate with exceptional work experienceAt least 5 years experience working in a clinical research settingAt least 3 years in a leadership or managerial position is preferredValid GCP Certificate (compulsory)Experience in auditing, monitoring, and maintaining clinical trials according to GCP standards (site files and patient folders)Experience in obtaining and adhering to regulatory requirements (SAHPRA, HREC)Experience in data collection and capturing within research is advantageousExperience in external audit processes is advantageousKnowledge of medical terminology (especially TB/HIV/COVID-19)Good Computer Literacy (MS Word, MS Excel, MS Outlook, and Internet; Data Management Systems advantageous)Excellent work ethic, interpersonal, communication and time management skillsAbility to motivate othersAbility to work independently and display initiative Language: English.
Afrikaans/Xhosa advantageous Responsibilities include (but not limited to):Maintaining and preparation of the Site Investigator Files (ISF) and Trial Master Files (TMF), including management and tracking of regulatory submissionsEnsuring superior quality assurance and quality control of Investigator Site Files, by frequent monitoring and general oversightPerforming the Informed Consent, Inclusion and Exclusion criteria QC processes and ensuring completion of corrections in all participant foldersEnsuring superior quality assurance and quality control across participant folders by per-visit monitoring and utilisation of all department trackersEscalating all deviations and safety or general concerns timeously as per organisational chart.Following up on all corrective actions to ensure completionEnsuring that the latest versions of the Clinical Trials Protocols, Investigator Brochures and ICFs are filed in the Investigator Site File, and tracked as necessarySupporting the QA department and Manager with administrative tasks as requiredAssisting with all the preparation and management of all monitoring and auditing visits (internal and external) as requiredSupporting and supervising other site staff with day-to-day quality control activities and training as requiredEnsuring familiarity with protocol overviews for each studyPreparing content for and attending meetings as requiredAdditional Information:This position will be based in Cape TownWorking hours 40 hours per week, Monday to Friday12-month contractOnly shortlisted candidates will be contacted.
Should you not receive a response within 30 days of the closing date, please consider your application unsuccessful. The University of Cape Town Lung Institute is committed to equity in our employment practices and reserves the right not to appoint.The selection process will be guided by the Employment Equity Plan and Targets of the University of Cape Town Lung Institute (Pty) Ltd. *Please Note: This Position is not on UCT Conditions of Service.