Project Manager - Human Sciences Research Council (CCBR Division)
(2022-04)
To provide administrative, operational, and project management support for clinical research activities across multiple projects within the CCBR Division. Coordination of clinical site requirements and providing support to clinical study staff, along with oversight of procurement, financial administration (participants reimbursements), quality assurance, and stakeholder communication to ensure the smooth execution of clinical trials and public health research initiatives.
- Coordinate and oversee day-to-day operations of clinical research projects across multiple studies
- Support implementation of study protocols and track progress against project milestones
- Provide logistical support to site teams and assist in resolving operational challenges
- Monitor recruitment and retention of study participants
- Training of study teams on new protocols and SOPs
- Liaise with clinical study staff to understand and meet site needs
- Ensure timely delivery of study supplies and materials to clinical sites
- Coordinate study initiation activities, including site readiness and investigator support
- Oversee the administrative coordination of procurement processes, including sourcing, purchase requisitions, tracking orders, and vendor follow-ups
- Ensure timely and cost-effective procurement of laboratory and study consumables in line with budgetary and compliance requirements
- Maintain accurate records of procurement and support audit readiness
- Conduct or support internal quality checks to ensure adherence to GCP and SOPs
- Assist in preparing for audits, maintaining essential regulatory and study documentation
- Ensure ethical and regulatory compliance of all study-related activities
- Maintain project documentation including protocols, ethics submissions, and reports
- Overall oversite of the Investigator site file (ISF)
- Coordinate updates and progress reports to investigators, partners, and funders as needed
- Serve as a point of contact for project-related queries and updates
- Support collaboration between internal teams, external partners, funders, and vendors
- Provide broader administrative and operational support to the research clinic Division as required
- Contribute to clinic planning, reporting, and coordination with senior management
Senior research Nurse - CAPRISA
(2020-12 - 2022-12)
- Playing a key role as patient advocate, ensuring patients' safety and protection, and that patients are well supported
- Cooperation with other researchers and members of the multidisciplinary team i.e. Principal Investigator and Sub- Principal investigators
- Screening and recruiting patients for the trial, obtaining informed consent from the Participants or carer if the patient lacks mental capacity as defined by the Mental Capacity Act 2005, reporting adverse events, collection of essential data and educating staff. These roles are conducted whilst adhering to the trial protocol and the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) standards for research.
- Following participants through the study, ensuring they attend all necessary visits as per protocol.
- STI Screening and Management
- Phlebotomy procedures for sample collection and preparation for storage and shipment. HIV testing and viral load monitoring for viral suppression or drug resistance. Counselling and follow up to ensure retention to care.
- Physical examination
- Pelvic examination
- Contraceptive provision and counselling (IUD insertions, Jaddelle implant insertions and DMPA injections) and management of side effects
- Referral of participants to relevant health care when they seroconvert for further management and treatment
- HIV counselling, risk reduction counselling.
- PrEP initiation, screening and monitoring participants on PrEP, giving them counselling, guidance and support
- Administering of medication for sexually transmitted infection, including hepatitis B vaccination.
- Safety reporting of untoward reaction obtained during participant consult and referral to institution for treatment when necessary.
- Health education and counselling to participants
- Participate in retention procedures
- Conducting interviews and focus group discussions on the study participants
Research Nurse - Wits health consortium (Match Research Unit)
(2012-01-01 - 2017-02-28)
Projects: FACTS001 TENOFOVIR Gel study (2012-01-01 to 2015-06-30), IPM 027 Dipivefrine Ring Study (2015-07-01 to 2015-12-31). ECHO STUDY (2016-01-01 to 2018). Position held: Research Nurse and Data Coordinator and line manager for Data team. Project: PEPEHC (2019 September to November 2020). Research Nurse role.
Research Nurse and Data Coordinator and line manager for Data team - Wits health consortium (Match Research Unit)
(2016-01-01 - 2018-12-31)
Overall coordinating of the data systems for the study.
- Conduct quality checks on study data to ensure that the data quality and integrity is up to standard by verifying that the information captured is attributable, legible, contemporaneous, original and accurate to meet the GCP standards.
- Manage new and ongoing queries through logging and resolving day to day queries and queries from data management center.
- Liaise with multiple stakeholders through constant communication to facilitate timeous queries resolution.
- Attending to the requirements and needs of the site CRAs when they are on site for study monitoring and attend to their findings.
- Leading the team in preparation for study audits.
- Day to day coordinating of data collecting and quality control of collected data.
- Ensuring that ALCOA principles and GCP is adhered to.
- Attending to QC Reports from Data management center.
- Liaising with data management center team for queries and direction with regards to data collection and queries resolution
- Training of new staff on Protocol, Sops and all study documents.
- Coordinate completion of Case Report Forms, quality checking and faxing to data management center.
- Developing of data collection tools to suit the protocol and standard operating procedures.
- Creation of Standard operating procedure to suit the study protocol.
- Translation of study documents to suit local language.
- Assist with compilation of statistical records for report writing purposes.
- Relieves the Project Manager when not on site.
Research Nurse - UKZN school of medicine
(2019-01 - 2019-09)
Project: CAP001 (PrEP study on pregnant woman). Overall coordinating of the data systems for the study.
- Playing a key role as patient advocate, ensuring patients' safety and protection, and that patients are well supported
- Cooperation with other researchers and members of the multidisciplinary team i.e. Principal Investigator and Sub- Principal investigators
- Screening and recruiting patients for the trial, obtaining informed consent from the Participants or carer if the patient lacks mental capacity as defined by the Mental Capacity Act 2005, reporting adverse events, collection of essential data and educating staff. These roles are conducted whilst adhering to the trial protocol and the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) standards for research.
- Following participants through the study, ensuring they attend all necessary visits as per protocol.
- STI Screening and Management
- Phlebotomy procedures for sample collection and preparation for storage and shipment. HIV testing and viral load monitoring for viral suppression or drug resistance. Counselling and follow up to ensure retention to care.
- Physical examination
- Pelvic examination
- Contraceptive provision and counselling (IUD insertions, Jaddelle implant insertions and DMPA injections) and management of side effects
- Referral of participants to relevant health care when they seroconvert for further management and treatment
- HIV counselling, risk reduction counselling.
- PrEP initiation, screening and monitoring participants on PrEP, giving them counselling, guidance and support
- Administering of medication for sexually transmitted infection, including hepatitis B vaccination.
- Safety reporting of untoward reaction obtained during participant consult and referral to institution for treatment when necessary.
- Health education and counselling to participants
- Participate in retention procedures
- Conducting interviews and focus group discussions on the study participants
- Conduct quality checks on study data to ensure that the data quality and integrity is up to standard by verifying that the information captured is attributable, legible, contemporaneous, original and accurate to meet the GCP standards.
- Manage new and ongoing queries through logging and resolving day to day queries and queries from data management center.
- Liaise with multiple stakeholders through constant communication to facilitate timeous queries resolution.
- Attending to the requirements and needs of the site CRAs when they are on site for study monitoring and attend to their findings.
- Leading the team in preparation for study audits.
- Day to day coordinating of data collecting and quality control of collected data.
- Ensuring that ALCOA principles and GCP is adhered to.
- Attending to QC Reports from Data management center.
- Liaising with data management center team for queries and direction with regards to data collection and queries resolution
- Training of new staff on Protocol, Sops and all study documents.
- Coordinate completion of Case Report Forms, quality checking and faxing to data management center.
- Developing of data collection tools to suit the protocol and standard operating procedures.
- Creation of Standard operating procedure to suit the study protocol.
- Translation of study documents to suit local language.
- Assist with compilation of statistical records for report writing purposes.
- Relieves the Project Manager when not on site.
Phlebotomist - Ampath Laboratories
(2010 - 2011)
- Collection of blood and other specimens from patients in and out of hospital for analysis in the laboratory.
- Handling of specimen in preparation for testing
- Entering of patients Data in the system
- Giving results out to the doctors telephonically.
Professional Nurse - Greys hospital
(2006 - 2010)
Worked in medical, surgical, outpatient and Neonatal Intensive Care Units. Holistic patient care as per registered nurse scope of practice.
- Assisted the doctors with invasive procedures and intubation and insertion of invasive line.
- Commenced invasive and non-invasive mechanical ventilation, oscillation or NC pap to neonates as required.
- Assisted with some management duties e.g. Mentoring of staff (this included training on procedures and conducting evaluations). Stock control and organizing of staff.
- Adherence to infection control
- Staff training
- Management of the unit in the absence of Unit manager.
- Also worked in other department i. e Medical, Surgical, orthopedics, pediatrics and maternity wards during the time spent in this Hospital.
