HIV Research Nurse
i have been working in clinical research for the past 8 years and have gained a lot of experience in how clinical trials operate especially in the Hiv prevention field. Currently working as a Clinical Quality Improvement Mentor. doing Quality control and assurance and mentoring nurses. working closely with regulatory Compliance Officer, study coordinator and PI.
Clinical Quality Improvement Mentor in Microbicides Trial Network
Wits Reproductive Health and HIV Institute
From January 2011
(WRHI) formerly RHRU as a Clinical Quality Improvement Mentor in Microbicides Trial Network (MTN) trials: MTN 020 which is a Multi-Centre-Randomized, Double-blind, Placebo-Controlled Phase 3 safety and effectiveness Trial of a vaginal Matrix Ring containing Dapivirine for prevention of HIV-1 infection in women.
DUTIES AND RESPONSIBILITIES:
• Work with the study coordinator/research clinician to ensure that clinical assessment of participants, as well as appropriate referral of participants that experience research-related outcomes, is conducted as per the protocol and SSP
* Supervise and provide clinical support and training to research nurses
* Play a significant role in quality control and quality assurance
* Assess the needs for a quality improvement programme in the clinical focus area as allocated and align to Institutes strategic goals
* Implement, monitor and review the quality improvement programme developed based on a comprehensive assessment of the needs and priorities of the study projects
* Work with the data manager and regulatory compliance officers to ensure that quality control reviews are completed, that queries are resolved rapidly to ensure that data fax turnaround times are adhered to * Identify problem areas in data collection and recording and plan training sessions to address these with the staff members concerned
* Liaise with the CLO about recruitment and retention activities to ensure that the site is on track with its targets and outputs
* Work with RCO to coordinate monitoring visits and debriefings.
* Produce relevant monthly reports on STI treatment, condom dispensing and any other trial related activities as required by the Study Coordinator
* Participate as a member of the research team in meetings and ensure communication and information sharing within the team and between the project and other research activities within the institute
Senior Research Nurse
Microbicides Trial Network
January 2010 - December 2010
(MTN) trials: MTN 003 study Protocol Title: A Phase 2B safety and effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumerate Tablet and TDF-Emtricitabine Tablet for the Prevention of HIV Infection in Women; MTN 015 Study Protocol Title: An Observational Cohort Study of Women following HIV-1 Seroconvertion in Microbicides trials; MTN 016 Study Protocol Title: HIV Prevention Agent Pregnancy Exposure Registry: Evaluation of Maternal and Baby outcome Registry After Chemoprophylactic Exposure ( EMBRACE ).
DUTIES AND RESPONSIBILITIES:
• Informing participants about the study
• Screening potential participants, obtaining informed consent according to standard operating procedures
• Administering study questionnaires / interviews
• Conduct pre and post HIV test Counseling.
• Clinical assessments, including:
• Drawing blood from participants
• Physical examinations, including genital examinations
• Performing HIV and pregnancy bedside tests
• Informing participants of test results
• Treating diagnosis according to test results.
• Treating Sexually transmitted disease according to syndromic management guidelines or laboratory diagnoses
• Provide appropriate health education and adherence counseling where necessary
• Referring participants to alternative care if necessary
• Performing sample related activities such as labeling, storage and collection
• Controlling and ordering consumable stock
• Keeping stock and ordering testing kits.
• Ensuring all used speculum and equipment are cleaned and sterilized
• Maintaining full clinical records for all participants
• Maintaining inventory register of drug stocks, laboratory samples, promotional materials and condoms
• Submission of relevant reports, verbal and written, on all activities
• Attendance and contribution to relevant meetings
• Contributing to maintenance of project filing and record keeping
• Quality control of Case report forms (CRF) and other study documents in keeping with GCP and...
Senior Research Nurse on the Microbicides Development
Programme (MDP), Protocol Title
An International multi-center, phase 3 study, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HIV infection. This was with Reproductive Health and HIV Research Unit (RHRU). Duties included but not limited to:
• Obtaining Informed consent according to standard operating procedures.
• Conducting interviews on participants and completing CRF'S per GCP guidelines.
• Doing HIV counseling and testing as per standard operating procedures.
• Doing genital exams and collecting vaginal swabs and bloods.
• Performing physical exams, diagnosis and referral.
• Diagnosing and treating sexually transmitted infection using the syndromic approach
• Doing quality control of data collected on CRF'S
• Ordering and maintaining inventory of laboratory stock.
• Giving health talks to participant including on community radio shows.
Pediatric experience: involved doing assessment on babies of participants who became pregnant whilst using study product at 6weeks post delivery. The assessments involved doing as physical exam to assess general wellbeing of the infant, check any congenital anomalies and checking for milestones and referrals when applicable. Assessing general wellbeing of mothers post delivery, including genital exams to check for any birth injuries and condition of episiotomies were relevant.
Clinix Private Hospital
in a male medical ward.
Chiawelo Community Clinic
in post-natal clinic
Performing infant physical exams
Immunization of Infants
Performing examinations on the mothers.
Chris Hani Baragwanath Hospital
Phase 2B Safety and effectiveness study of Tenofovir 1% Gel,Tenofovir disoproxil fummerate tablet and emitrictabine tablet for the prevention of HIV in women.
MTN 020 Aspire
a multi Centre randomized, double blind, Placebo controlled phase 3 safety and effectiveness trial of a vaginal matrix ring containing dapivirine for the prevention of HIV-1 infection in women.
Phase 3 clinical trial
Qualifications & Certifications
Fidelitas Secondary School
Chris Hani Baragwanath Nursing College
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