Clinical Research Team Lead
16 hours ago
We are seeking a highly skilled and experienced Clinical Research Team Lead to join our team at the University of Cape Town Lung Institute. The successful candidate will be responsible for leading a team of clinical research professionals and ensuring the highest standards of quality and compliance in our clinical trials.
Key Responsibilities:- Maintain and prepare Site Investigator Files (ISF) and Trial Master Files (TMF)
- Ensure superior quality assurance and quality control of Investigator Site Files through frequent monitoring and general oversight
- Perform Informed Consent, Inclusion and Exclusion criteria QC processes and ensure completion of corrections in all participant folders
- Ensure superior quality assurance and quality control across participant folders through per-visit monitoring and utilization of all department trackers
- Escalate all deviations and safety or general concerns timeously as per organisational chart
- Follow up on all corrective actions to ensure completion
- Ensure that the latest versions of Clinical Trials Protocols, Investigator Brochures and ICFs are filed in the Investigator Site File, and tracked as necessary
- Support the QA department and Manager with administrative tasks as required
- Assist with all preparation and management of monitoring and auditing visits (internal and external) as required
- Support and supervise other site staff with day-to-day quality control activities and training as required
- Ensure familiarity with protocol overviews for each study
- Prepare content for and attend meetings as required
- Bachelor of Science Degree or Degree in Health Sciences (advantageous) OR Grade 12 / Senior Certificate with exceptional work experience
- At least 3-5 years experience working in a clinical research setting
- At least 2 years in a leadership or managerial position is preferred
- Valid GCP Certificate
- 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 advantageous
- Experience in external audit processes is advantageous
- Knowledge 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 skills
- Ability to work independently and motivate others
- 6 to 12-month fixed term contract
- Working hours - 40 hours per week, Monday to Friday
- This position will be based in Mowbray, Cape Town
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