Summary
Overview
Work History
Education
Skills
Certification
References
Interests
Accomplishments
Affiliations
Publications
Timeline
Generic

Sylvesta Hildegard Hlophe

Senior Clinical Trials Associate
Johannesburg

Summary

Award-winning Clinical Research Professional with 10+ years of experience coordinating and monitoring multi-phase trials across diverse therapeutic areas, including HIV, Oncology, Overactive Bladder, Kidney Disease, Anti-emetics, and Bisphosphonates.


Trained peers on Oncology trial protocols, resulting in fewer site deviations, improved monitoring outcomes, and faster patient enrollment.


Won the best paper presented during SASMO and SACRO and the title was “Prognostic Factors In Meta Static Breast Cancer”

Overview

30
30
years of professional experience
8
8
years of post-secondary education
1
1
Certification
6
6
Languages

Work History

Senior Clinical Trials Associate

ICON
07.2023 - 05.2025
  • Onsite monitoring and site management. Site staff performance including participates in all types of site visits; assures compliance with all protocol requirement.
  • Managing studies involving Psoriasis and prostate cancer.
  • Phase II Trails Psoriasis and matter static and Phase II hormone resistant prostate cancer.
  • Assumed all responsibilities listed while at the previous company.
  • Monitoring: Have been responsible for the management of the following types of Trials within the past year: Phase II Oncology Trails and Phase II Psoriasis.

Principal Clinical Trials Associate

PPD
01.2019 - 10.2022
  • Onsite monitoring and site management and site staff performance including participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place. Assumed all responsibilities listed while at the previous company.
  • Monitoring: Have been responsible for the management of the following types of Trials within the past year: Phase II, III and IV clinical trials in HIV infected adolescents and children in their different indications.

Clinical Trials Associate

Clintec Outsourced to MSD
01.2016 - 12.2018
  • Clinical Research Associate on 3 global, randomized, double blind, phases III studies in adults with refractory Hodgkin’s Lymphoma, Multiple Myeloma and Non-Small Cell Lung Cancer and on 2 Registry studies in chemotherapy induced nausea and vomiting in both adult and paediatric population.
  • Participated in site selections and feasibilities. Performed pre-study, site initiation, both remote and onsite interim monitoring and close out visits. Increased subject recruitment rates by 30% across multiple sites through tailored recruitment strategies and continuous engagement with site coordinators.
  • Performed 100% source data verification (SDV) on high-risk sites and reduced monitoring for low-risk sites, contributing to a 25% reduction in monitoring time while maintaining full regulatory compliance. Participated in multiple interim analysis and database locks, ensuring timely and high quality data entry compliance from sites and query resolution within required timelines.
  • Ensured study subject safety and managed adverse event reporting and follow up. Administered protocol and related study training to sites and established regular lines of communication with them to manage ongoing project expectations and issues.
  • Completed monitoring visit reports and evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Performed IP management activities. Managed study systems and study documentation. Prepared site payments. Used eDiaries, CTMS, eTMF, eCRF and IWRS systems. Unblinded Principal Clinical Research Associate on a global, randomized, double blind, phase III study in metastatic Breast Cancer, adult population. Performed unblinded site initiation, interim monitoring and close-out visits. Completed unblinded monitoring visit reports and reported study progress. Conducted regular site contacts with unblinded site personnel to support the sites’ execution of their study responsibilities and to follow up on IP issues.
  • Acted as the primary contact for unblinded site personnel. Managed IP shipments and accountability.

In house Clinical Trials Associate 1 / CMA

INC Research
07.2014 - 12.2015
  • Anticipation and identification of potential issues at the site
  • Regulatory Documentation – Assurance of compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
  • Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participation in TMF and on-site audits as requested; may require guidance to respond to findings.
  • Assuming responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place.
  • Assuring timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; and regularly reviews the status of the contents within the site regulatory binder.
  • Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assurance of timely and accurate completion of data clarification forms.
  • Reporting and Tracking - Completes and submits visit reports according to SOP/Works Instructions (WI) requirements.
  • Maintenance and awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs.
  • Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA.
  • Tracks Investigator payments milestones. Documentation and tracking the resolution of all outstanding site-specific protocol-related issues from visit to visit.
  • Assisted with the preparation of study start up materials and tools.
  • Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
  • Remote monitoring and site management/coordination activities of all phases of studies (including Phase I studies)
  • Provide site identification support including but not limited to distribution of site questionnaires, assisting with CDA distribution, tracking and finalization, confirming and tracking site participation status using the appropriate reporting tool
  • Communicates site status and updates to the assigned CRA and LeadCRA Ensures site maintains an appropriate supply inventory (investigational product, lab kits, etc.)

Clinical Trial Coordinator

Dr Bernardo Leon Rapoport : Medical Oncologist
04.2007 - 07.2014
  • Company Overview: The Medical Oncology Centre Of Rosebank, Johannesburg
  • Reviews of new protocols and other materials provided by study sponsors and gives input to Principal Investigator, regarding Nursing and Research issues in order to determine financial and clinical feasibility.
  • Coordination and implementation of various protocols for assigned Research projects with appropriate departments throughout by interacting with Principal Investigators and Clinical Managers/Supervisors, providing in-service education for healthcare professionals and working with Pharmacy to ensure a smooth project flow.
  • Assists with preparation of Institutional Review Board (IRB) materials related to initial review and approval of the study.
  • Maintaining communication with study sponsor and/or designee throughout study. Complete feasibility questionnaires.
  • Assisting in maintaining regulatory binders.
  • Helps ensures applicable study supplies, including study drug and/or devices, are received prior to study initiation.
  • Develops field tests and critiques data collection forms and offers suggestions for revisions.
  • Develops appropriate protocol information sheets and pre-printed Physician Order sets for new investigational drug protocols and revises as indicated throughout the study period.
  • Screening of patients for eligibility on assigned clinical trials in accordance with the protocol.
  • Coordination of Research subject consent and entry into appropriate Research studies ensuring that all inclusion and exclusion criteria are met.
  • Managing of Research subjects on assigned clinical trials, which include the following: Scheduling protocol required study visits
  • Ensuring that all protocol required testing and treatments are done per protocol Assessing patients for adverse events
  • Drawing pharmacokinetic and other research samples, and coordinating patient follow-up. Participates in daily clinic operations (Physician Offices and Inpatient Units where trials are being conducted) to include clinical assessment, education and delivery of patient care.
  • Administration of investigational drugs.
  • Performed various tasks, such as obtaining blood samples by phlebotomy, from arterial lines or central venous catheters in compliance with sponsor standards, centrifuging, specimen preparation, shipping and other related procedures.
  • Reporting of serious adverse events (SAEs) in a timely manner per study sponsor (or designee) and IRB requirements.
  • Assisting with regulatory compliance including assisting with preparing ethics materials for approval of protocol amendments, submitting IND Safety Reports to the ethics, completing ethics continuing review reports.
  • Accurately completes case report forms in a timely manner.
  • Completing all applicable Research billing compliance procedures.
  • Writing manuscripts for publications, writing, submitting and presenting papers at national and international meetings.
  • Coordination of study-monitoring visits.
  • Helping to ensure that all study related activities are complete including returning supplies, returning unused stock of study drug/devices, and confirming that all queries are complete.
  • Helping to ensure that all study documents are complete and that records are retained per sponsor, state and institutional standards.
  • Maintenance of current knowledge of departmental functions through reading literature, attending workshops, seminars and conferences, and by participating in professional organizations.
  • Involved in development, implementation, and administers Research Nurse Policies and procedures of the practice.
  • Managed the development of Standard Operating Procedures.
  • Maintenance of study related equipment including calibrations.
  • Led regulatory quality audits and sponsors.
  • Maintains patient and study confidentiality at all times.
  • OTHER RESPONSIBILITIES
  • Oversee drug ordering of practice stock / payments to creditors
  • Informal education and training of study coordinators
  • Lecturing on different aspects of cancer, special interest: febrile neutropenia and chemotherapy related nausea and vomiting
  • Fostered strong cross functional collaborations with medical specialists and pharmaceutical partners, enhancing protocol adherence and trial efficiency.
  • Section 21 drug applications.

Charge sister Oncology ward

Linksfield Park Clinic
01.1999 - 12.2001
  • Nursing care of Oncology Patients
  • Administration of chemotherapy and management of chemotherapy side effects. Administration of blood and blood products.
  • Management of oncological emergencies e.g Febrile Neutropenia, Spinal Cord Compression Management of chemotherapy induced nausea and vomiting.
  • Management of Central venous accesses (A-Port).
  • Administration of drugs related to clinical trials.
  • Patient counselling.
  • Management of intensive care patients.

Chemotherapy Nursing Sister

Garden City Clinic
01.1996 - 12.1999
  • Nursing care of Oncology Patients
  • Administration of chemotherapy and management of chemotherapy side effects. Administration of blood and blood products.
  • Management of oncological emergencies e.g Febrile Neutropenia, Spinal Cord Compression Management of chemotherapy induced nausea and vomiting.
  • Management of Central venous accesses (A-Port).
  • Administration of drugs related to clinical trials.
  • Management of intensive care patients.

General nursing Sister

Murchison Hospital
01.1995 - 12.1995
  • Worked on a rotation basis within the following units:
  • Medical ward
  • Surgical ward
  • Maternity ward
  • And casualty (management of all emergencies)

Education

Matric - English, Afrikaans, Biology, Maths, Physics, Xhosa, Agriculture

Nkwanca High School

Diploma - Nursing, General, Psychiatry, Community and Midwifery

Baragwanath Nursing College
01.1990 - 01.1994

Introduction to computers, Microsoft Word, PowerPoint and Excel

Unischool
01.2000 - 01.2000

MSc - Oncology Nursing

University of the Witwatersrand
01.2002 - 01.2006

Introduction to Intensive care Unit

Netcare College
01.2000 - 01.2000

Skills

Extensive experience of Microsoft Office and Internet knowledge skills

Certification

Oncology Nurse

References

Margaret, Karime, +27 (0) 83 377 4799

Interests

Food - bagel roll on cheese is my guilty pleasure, Traveling - 27 countries, Recently picked up jogging, Reading - Sydney Shaldon, Gardening - I have one beautiful huge garden I love taking care of

Accomplishments

  • NETCARE CARER OF THE MONTH MARCH 2001
  • YOUNG INVESTIGATOR AWARD SASMO/SACCRO BREAST CANCER PAPER PRESENTATION 2003 (BLOEMFONTEIN).
  • LEO CATCH PHARMACEUTICALS: COORDINATOR OF THE MONTH NOVEMBER 2012

Affiliations

ONCOLOGY NURSING SOCIETY - MEMBER

Publications

  • Authored the thesis titled “Screening behaviors of women with 1st degree relatives diagnosed with breast cancer” was presented to the University of the Witwatersrand in 2005. As a result, earned a Masters’ Degree in Oncology Nursing in 2006 at the University of Witwatersrand, Johannesburg, South Africa.
  • Other publications:
  • 1. Phase II study of pegylated liposomal doxorubicin and carboplatin in patients with platinum-sensitive and partially platinum-sensitive metastatic ovarian cancer.
  • 2. Evaluation of circulating soluble triggering receptor expressed on myeloid cells-1 (sTREM 1) to predict risk profile, response to antimicrobial therapy, and development of complications in patients with chemotherapy-associated febrile neutropenia: a pilot study.
  • 3. Phase II study of combination therapy with pegylated liposomal doxorubicin (PLD)and carboplatin in patients (pts) with relapsed, platinum sensitive and platinum semi-sensitive ovarian cancer Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post Meeting Edition). Vol 26, No 15S (May 20 Supplement), 2008: 5555.

Timeline

Senior Clinical Trials Associate

ICON
07.2023 - 05.2025

Principal Clinical Trials Associate

PPD
01.2019 - 10.2022

Clinical Trials Associate

Clintec Outsourced to MSD
01.2016 - 12.2018

In house Clinical Trials Associate 1 / CMA

INC Research
07.2014 - 12.2015

Clinical Trial Coordinator

Dr Bernardo Leon Rapoport : Medical Oncologist
04.2007 - 07.2014

MSc - Oncology Nursing

University of the Witwatersrand
01.2002 - 01.2006

Introduction to computers, Microsoft Word, PowerPoint and Excel

Unischool
01.2000 - 01.2000

Introduction to Intensive care Unit

Netcare College
01.2000 - 01.2000

Charge sister Oncology ward

Linksfield Park Clinic
01.1999 - 12.2001

Chemotherapy Nursing Sister

Garden City Clinic
01.1996 - 12.1999

General nursing Sister

Murchison Hospital
01.1995 - 12.1995

Diploma - Nursing, General, Psychiatry, Community and Midwifery

Baragwanath Nursing College
01.1990 - 01.1994

Matric - English, Afrikaans, Biology, Maths, Physics, Xhosa, Agriculture

Nkwanca High School

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Sylvesta Hildegard HlopheSenior Clinical Trials Associate