Nokhanyo Xaba

Prior to initiation of the study:

• Supported project manager in preparation of documents to obtain study approval from all local relevant authorities, including drug license importation;
• Reviewed and ensured conformity with local requirements and GCP requirements all study documents relevant to site, including study protocol, patient information screening tool, informed consent form (ICF) etc.;
• Managed translations, as required;
• Participated to recruitment of site staff;
• Ensured completion of logistical preparation for study site;
• Ensured that all study staff is trained according to protocol, operating procedures and GCP;
• Initiated Investigator Site File (ISF) and ensure that all essential documents to start recruitment are filled in the maintained as per government and IRB regulatory requirements

During recruitment in the trial:

• Provided support to clinical investigators with subject recruitment in accordance with protocol, effective SOP, GCP and applicable regulatory requirements;
• Collaborated with internal monitor to ensure that site staff is compliant with GCP, applicable regulations, particularly in ethical issues and in agreement with protocol and effective SOPs;
• Monitored study progress and prepare monthly progress report;
• Ensured that any new staff hired after study initiation has been trained in GCP and study protocol;
• Maintained Investigator Site File (ISF);
• Supported Site PI for submission of any amendment to protocol or ICFs for approval to IRB and ethics committees;
• Ensured with Site PI that notifiable events are reported on time to the Study Coordinator and to relevant ethics committee(s) and regulatory authorities;
• Ensured data is recorded, handled, stored and reported accurately and promptly and confidentiality is maintained;
• Provided patient data and screening log to central research team and external monitor or any audit, when required;
• Coordinated study visits for all study participants;
• Supervised Senior Research Associates, Research Associates, Data Officers, Community Screeners and other site positions essential to implementation of the FIND Project
• Been in constant communication with Site PI, and the central research team for: Study update Safety issues Any issue related to protocol deviation(s) Any specific concern related to human specimen analysis
• Any request of study related document amendment

• Ensure patients are recruited according to inclusion criteria
• Follow up on patients according to study protocol
• Making sure that study data collection tools are correctly filled in, and analysis of data happens on regular basis
• Ensure good communication within team on correct management of equipment and/or materials that are specific for study
• Ensure professional confidentiality is respected.
• In case unexpected situations lead to proposal of amendment, discuss with all co-investigators proposed protocol changes
• Ensure amendment documents are correctly filled in
• Follow-up on submission of amendment to ethics committees and feedback
• Assist in further adapting protocol based on ethics feedback
• Provide technical support to TB Research Associates (RAs) and TB supervisor on TB-related topics
• Ensure ongoing training of medical multidisciplinary team in order to optimize quality of care for TB patients
• Analyze the patient flow in the clinics and/or hospitals to help develop systems to integrate the study into the existing system

• Explaining and answering questions about research,
• Recruit and screen 170 volunteers from target populations
• Provide qualitative and quantitative feedback on recruitment strategies
• Maintain confidentiality and ethical standards during recruitment
• Provide counselling and data collection activities, including: Administering screening questionnaires
• Provide counselling to volunteers
• Properly document all counselling sessions
• Assist with enrolment
• Provide risk-reduction counselling
• Retention of Volunteers
• Obtain, verify and update detailed locator data
• Maintain locator and retention data base
• Conduct visit reminders
• Track participants as needed
• Recommending retention strategies to superiors
• Ensure all applicable documentation are completed accurately
• Administer data collection instruments
• Complete, compile and submit study case report forms
• Ensure all records on participants are completed and filed accurately
• Maintain accurate study logs
• Report on daily/weekly activities
• Assist with SOP development
• Liaise with External and Internal Customers:
• Liaise with all Internal Customers and External Customers
• Participate in training, meetings and other activities
• Comply with all safety policies, practices and procedures
• Participate in proactive team efforts to achieve study goals

• Responsible for registrations
• Responsible for filing and other administration duties
• Worked directly with people to sell company name
• Dealt with inbound and outbound calls to address customer enquiries

• Worked as student research assistant for supervisor Prof Pranitha Maharaj
• Assisted in literature review for research studies on Elderly and Technology
• Interacted with research subjects
• Researched and presented on different topics

• Applied advanced computer skills and knowledge of Oracle on daily basis
• Discussed options with clients and determined appropriate plans
• Delivered high level of service to clients to both maintain and extend relationships for future business opportunities
• Contacted customers as soon as issues arose to immediately find resolution before problems escalated
• Documented changes to customer accounts, including payment details and personal information.