Henrietta Bouwer
Senior Clinical Research Associate
Pretoria,GP
Summary
Dynamic Senior Clinical Research Associate with extensive experience at IQVIA RDS CLINDEPHARM, excelling in risk management and regulatory adherence. Proven track record in enhancing data integrity and fostering effective communication among cross-functional teams, ensuring compliance with ICH-GCP standards while driving successful trial outcomes.
Overview
21
21
years of professional experience
2
2
Languages
1
1
Certificate
4
4
years of post-secondary education
Work History
Senior Clinical Research Associate
IQVIA RDS CLINDEPHARM (Pty) Ltd
08.2022 - Current
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Communicated project status to clinical operations management verbally and through technical documentation and presentations.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
- Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
- Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
- Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Senior Clinical Research Associate II
COVANCE INC. / LABCORP CLINICAL DEVELOPMENT
02.2016 - 07.2022
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
- Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Communicated project status to Central Operations Management verbally and through technical documentation and presentations.
- Communicated project status to [Type] management verbally and through technical documentation and presentations.
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Clinical Research Associate (II & III)
PAREXEL SA
07.2007 - 01.2016
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Liaised with [Type] department personnel to communicate important clinical data and events.
- Created and maintained database and records filing system to document data on specimen collection, processing and storage.
- Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
- Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
- Assisted in the preparation of regulatory submissions, supporting successful approval for clinical trials.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Supported development and delivery of department training to maximize success of clinical research.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Improved patient enrollment by developing and implementing effective recruitment strategies.
- Maintained awareness of industry trends by attending conferences and participating in relevant professional development opportunities.
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Contributed to the development of study documents, including informed consent forms and case report forms.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
- Leveraged [Type] knowledge, expertise and problem-solving techniques to resolve investigative site issues.
- Applied extensive [Type] knowledge to troubleshoot and resolve regulatory document issues.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Participated in the review of clinical trial data during preparation of final study reports, highlighting key findings for further analysis or publication purposes.
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Clinical Research Coordinator
MIDRAND
05.2004 - 06.2007
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
- Assisted in drafting comprehensive research reports summarizing findings, conclusions, and recommendations for further action.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Conducted site visits to monitor trial conduct and provide on-site support, ensuring high-quality data collection.
- Streamlined process for serious adverse event reporting, enhancing safety monitoring efforts.
- Monitored adverse events and ensured timely reporting to regulatory bodies, maintaining high safety standards.
- Facilitated successful trial completion by closely monitoring study timelines and milestones, ensuring on-time delivery of results.
- Improved data integrity and accuracy with meticulous oversight of data collection processes.
- Oversaw ethical conduct of clinical trials, ensuring all activities were in accordance with ethical guidelines.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Education
Bachelor of Science - Human Nutrition & Dietetics
University of Stellenbosch
Stellenbosch, South Africa 02.1982 - 12.1985
Skills
Risk management reporting
Timeline
ICH GCP E6 (R2) and SA GCP (v3-2020)
03-2024
Senior Clinical Research Associate
IQVIA RDS CLINDEPHARM (Pty) Ltd
08.2022 - Current
Senior Clinical Research Associate II
COVANCE INC. / LABCORP CLINICAL DEVELOPMENT
02.2016 - 07.2022
Clinical Research Associate (II & III)
PAREXEL SA
07.2007 - 01.2016
Clinical Research Coordinator
MIDRAND
05.2004 - 06.2007
Bachelor of Science - Human Nutrition & Dietetics
University of Stellenbosch
02.1982 - 12.1985
Certification
ICH GCP E6 (R2) and SA GCP (v3-2020)
Accomplishments
1. Collaboration with Management Team led to training, developing and mentoring junior CRAs to become confident leaders in the work environments.
2. CRA's confidence and knowledge of clinical trial tasks and leadership roles excelled when assigned as:
*CQC Assessor for South Africa (Jun-2019)
*Trip Report Reviewer for
- USA Phase III Contraceptive Efficacy and Safety Study (Jul-2017 - Mar-2018)
- iNHL Phase III Indolent Non-Hodgkin's study (Aug-Nov-2017)
- Global Phase III Cystic Fibrosis Study (Apr -Jun-2017)
and providing assistance with
- BID Proposal for Malaria Study in Kenya (Feb-2017)
3. Achieved timely closure of the two global Phase 1b and III studies (2017-2019) when assisting with the eTMF reviews and preparation for transfer to clients.
4. Successful recruitment and closure of clinical trials in Africa were achieved by PI's, Site Staff and the Sponsor with commitment, dedication, teamwork and desire to learn more. These included
- Regional CRA Lead - HIV-Paediatric Study - Uganda and Tanzania (Aug-2012 - Jul-2014)
- Regional Clinical Lead - Latent TB study (2010-2011)
- Regional Clinical Lead - Impetigo study (2009-2011)
5. Achieved collaboration and excellent team work through effectively and successfully conducting qualification visits and identification of sites for different studies in South Africa and Africa (Malaria study in Kenya, Uganda, Malawi, Zambia)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
RemoteHybridImportant To Me
Work from home optionFlexible work hoursCareer advancementHealthcare benefitsPersonal development programsCompany CultureWork-life balanceTeam Building / Company RetreatsPaid time offPaid sick leaveStock Options / Equity / Profit SharingLanguages
English
Bilingual or Proficient (C2)
Afrikaans
Bilingual or Proficient (C2)
Interests
Sport - Rugby, Cricket, Tennis, Athletics, Basketball
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