16 Drug Development jobs in South Africa
Research Scientist
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Job Description
To provide scientific leadership, mentorship and support to multi-disciplinary teams in the laboratory environment at the Platform.
Technology Innovation Agency (TIA) is a talent driven, customer- centric and impact focused organisation. In our endeavour to support technology innovation with socio-economic outcomes; we seek to infuse the organisation with team players that find resonance as value creators, agile thinkers, progressive attitudes, customer-centricity, dynamic work ethic and an optimistic disposition. We aim to harness these attributes in a manner that they culminate into a culture of teamwork, impact and accountability.
In executing its mandate, the organisation provides funding and non-funding support to stimulate innovation so that it provides a catalytic impact to the economy whilst improving people's lives and protecting the environment. The Agency endeavours to promote the careers of previously disadvantaged persons by applying the principles of the Employment Equity Act, as amended.
The agency reserve thed right not to fill this position.
Minimum RequirementsQualifications
- MSc Molecular Biology, Biotechnology, Biochemistry or Microbiology
- Preferred: PhD degree
Work Exprerience
- 4 years' experience in the relevant scientific field.
- Be registered with the relevant professional legislated regulatory body. i.e. HPCSA, SACNASP
Finance
- Give input to the formulation of the operational budget and monitor and track applicable spending.
- Provide leadership with expenditure undertaken by the diagnostic section
- Manage and monitor financial obligations that projects have to TIA (e.g. service fees, generation of service quotes, invoices etc)
- Solicit additional funding through submission funding proposals
Stakeholder Relations Plans
- Assume custodianship for linking the Platform and diagnostic section with relevant accreditation authority.
- Manage effective internal and/or external Stakeholder relationships:
- Deliver required service to the stakeholder on brief, time and with quality
- Respond timeous to queries of the stakeholder
- Maintain professional engagements and continuously exceed expectations
Internal Processes
- Lead a multidisciplinary team in diagnostic section, to deliver on approved assignment and assays.
- Provide project management and leadership on assigned projects including project costing
- Provide critical input into the operational plan of the Platform with regards to the area of expertise, i.e. diagnostic sections.
- Lead process of certifying the Diagnostic section in according to the relevant requirement i.e. SANAS. DoH etc
- Develop research protocols and SOP for the laboratory with assistance from other Platform scientists
- Ensure timeous and accurate reporting as per requirements to clients, funders, and other stakeholders. Prepare technical reports, summaries and protocols of the reports
- Compile internal and external proposals with input from the Platform technical team & complete external project review forms
- Ensure adherence to all legal compliance and business processes
- Conduct a technical feasibility study and project definition meeting
- Define a consolidated project plan with deliverables as identified in the project definition meeting
- Source approved equipment and consumables and manage stock levels
- Manage the lab equipment and oversee the general housekeeping of the laboratory.
- Manage SLA's and service received from providers.
- Develop new products and processes at the Platform: Design experiments, analyses results and compile SOP's and test methods in line with client needs and statutory requirements.
- Trouble shoot experimental problems and find solutions
- Draft and publish scientific and technical papers
Governance and Compliance
- Ensure compliance with Legislation, e.g. PFMA and National Treasury Guidelines;
- Ensure compliance to all relevant accounting Standards, Policies and Frameworks; and
- Ensure Compliance with TIA Standard Operating Procedures
- Be registered with the relevant professional legislated regulatory body. i.e. HPCSA, SACNASP
Vacancy: Ethnobotanical Research Scientist
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Job Description
Company Description
The Chirandu Group is a research-led enterprise advancing the science, provenance, and application of indigenous African knowledge. The Group unites research, formulation, and product innovation to develop verified systems of sensory and material intelligence that bridge culture and science. Through The Chirandu Institute and Chirandu Botanica, it conducts heritage documentation, sensory analysis, and formulation development to create credible, high-quality products rooted in African ecosystems.
We are looking for someone passionate about African indigenous and medicinal plants and how they can shape the future of clean, market-ready food, wellness, and personal care products.
In this part-time role, you will support our Lead Ethnobotanical Research Scientist with:
- Ethnobotanical mapping
- Profiling ingredients and bioactive compounds
- Structuring African Indigenous knowledge systems
If you are detail-oriented, research-driven, and excited to bring traditional wisdom into modern innovation, we would love to hear from you.
Role Purpose
The Ethnobotanical Research Scientist will support the research and developmental team by gathering, validating, and structuring African indigenous plant knowledge into standardized dossiers. These dossiers form the foundation of the company's knowledge archive, supporting downstream formulation, licensing, and product development.
Key responsibilities
- Research & document interdisciplinary knowledge on botany, phytochemistry, traditional uses and ecological sustainability of African indigenous plants.
- Populate ingredient dossiers and bioactive profiles using standardized templates provided by Chirandu Botanica.
- Reporting and documentation of research that is publication-worthy & aligns with both scientific and cultural perspectives.
- Identify overlaps, contradictions, and research gaps when profiling and mapping the plants.
- Participate in peer review sessions with the Lead Ethnobotanical Research Scientist.
- Contribute insights & incorporate feedback to improve the quality of dossiers, formulations and commercialization priorities.
- Support field visits, interviews, or data collection when needed.
- Ensure compliance with heritage and attribution protocols.
Qualifications & Experience
- Master's in Botany, Ethnobotany, Pharmacognosy, Ethnopharmacology, Medicinal Plant Chemistry, Phytochemistry, Natural Products Chemistry, or related field
- 2 years of research experience (experience must also be in industry, not just academic). and academic writing. (Publication is an added advantage)
- Experience with literature reviews and academic references.
- Familiarity with African indigenous knowledge systems
- Ability to work independently
- Familiarity with product development using indigenous medicinal plants will be an added advantage.
Email your CV and short motivational letter to
Only shortlisted candidates will be contacted. If you do not receive feedback within 2 weeks, consider your application unsuccessful.
Part-Time/Contract Ethnobotanical Research Scientist
Posted today
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Job Description
Chirandu Botanica is growing its research team We are looking for someone passionate about African indigenous and medicinal plants and how they can shape the future of clean, market-ready food, wellness, and personal care products.
In this part-time role, you will support our Lead Ethnobotanical Research Scientist with:
- Ethnobotanical mapping
- Profiling ingredients and bioactive compounds
- Structuring African Indigenous knowledge systems
If you are detail-oriented, research-driven, and excited to bring traditional wisdom into modern innovation, we would love to hear from you.
Role Purpose
The Ethnobotanical Research Scientist will support the research and developmental team by gathering, validating, and structuring African indigenous plant knowledge into standardized dossiers. These dossiers form the foundation of the company's knowledge archive, supporting downstream formulation, licensing, and product development.
Key responsibilities
- Research & document interdisciplinary knowledge on botany, phytochemistry, traditional uses and ecological sustainability of African indigenous plants.
- Populate ingredient dossiers and bioactive profiles using standardized templates provided by Chirandu Botanica.
- Reporting and documentation of research that is publication-worthy & aligns with both scientific and cultural perspectives.
- Identify overlaps, contradictions, and research gaps when profiling and mapping the plants.
- Participate in peer review sessions with the Lead Ethnobotanical Research Scientist.
- Contribute insights & incorporate feedback to improve the quality of dossiers, formulations and commercialization priorities.
- Support field visits, interviews, or data collection when needed.
- Ensure compliance with heritage and attribution protocols.
Qualifications & Experience
- Master's in Botany, Ethnobotany, Pharmacognosy, Ethnopharmacology, Medicinal Plant Chemistry, Phytochemistry, Natural Products Chemistry, or related field
- 2 years of research experience (experience must also be in industry, not just academic). and academic writing. (Publication is an added advantage)
- Experience with literature reviews and academic references.
- Familiarity with African indigenous knowledge systems
- Ability to work independently
- Familiarity with product development using indigenous medicinal plants will be an added advantage.
Email your CV and short motivational letter to
Only shortlisted candidates will be contacted. If you do not receive feedback within 2 weeks, consider your application unsuccessful.
Job Types: Part-time, Internship
Contract length: 6 months
Pay: R6 500,00 - R8 000,00 per month
Expected hours: 20 – 30 per week
Education:
- Masters (Preferred)
Experience:
- research and/or academic writing: 2 years (Preferred)
Work Location: In person
Research Scientist: Machine Learning and Statistical Modelling for Ocean-Climate Science
Posted today
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Job Description
The Council for Scientific and Industrial Research (CSIR) is a leading scientific and technology research organisation that research, develops, localises and diffuses technologies to accelerate socio-economic prosperity in South Africa. The organisation's work contributes to industrial development and supports a capable state. The CSIR has a vacancy for a Research Scientist: Machine Learning and Statistical Modelling for Ocean-Climate Science in the
The Council for Scientific and Industrial Research (CSIR) is a leading scientific and technology research organisation that researches, develops, localises and diffuses technologies to accelerate socio-economic prosperity in South Africa. The organisations work contributes to industrial development and supports a capable state.
Research Scientist: Machine Learning and Statistical Modelling for Ocean-Climate Science
About The Job
The Southern Ocean CarbonClimate Observatory (SOCCO) at the CSIR has a vacancy for
Researc
h
Scientist
in large-scale ocean carbon cycle processes that can apply machine learning, artificial intelligence, and statistical modelling to advancing understanding of global CO? fluxes and their direct policy relevance, positioning the researcher at the forefront of international climate science. By linking Southern Ocean research to global carbon cycle assessments, the successful candidate will work within a dynamic, world-leading team and help shape future strategies for carbon monitoring and management. This position is based in Cape Town.
Key Rsponsibilities
- Lead the development, refinement, and application of machine learning frameworks to improve surface ocean CO? flux estimates, building on SOCCOs flagship ML-based CO? flux product (CSIR-ML6).
- Lead RD and innovation in the development of emerging AI technologies and techniques and application in the field of ocean-climate research
- Evaluate the performance of Earth System Models (CMIP6/7) against the ML-based observational CO? flux product, focusing on:mean-state climatologies,spatial, temporal, and seasonal variability, andlong-term trends.
- Diagnose discrepancies between ocean-climate models and reconstruction products using Observing System Simulation Experiments (OSSEs) and advanced statistical approaches.
- Conduct high-resolution OSSEs to optimize Southern Ocean CO? observing strategies and reduce uncertainty in sink estimates.
- Supervise, train, and mentor postgraduate researchers, contributing to the growth of capacity in AI-driven climate science and advancing its integration into ocean-climate modelling
- Actively contribute to international science-policy processes such as the Global Carbon Budget and State of the Climate reports.
- Contribute actively to the development of competitive research proposals to secure external funding for long term sustainability of research activities.
Qualifications, Skills And Experience
- A Doctoral degree in Earth System Science, Oceanography, Applied Mathematics, Statistics, Computer Science, Data Science, or a related field; with atleast five years proven expertise in machine learning, AI, and high-performance scientific computing;
- At least five years experience applying supervised and unsupervised machine learning methods (e.g., neural networks, gradient boosting, clustering) to environmental or geophysical datasets, including development of approaches to improve predictive skill and model performance;
- Demonstrated ability to work with large, sparse, and heterogeneous datasets, including gap-filling, noise reduction, spatiotemporal post-processing, and integration of observational and model outputs;
- Ability to translate machine learning outputs into climate and environmental science applications;
- Demonstrated track record of international collaboration and publications in leading peer-reviewed journals;
- Excellent communication skills, including capacity-building and postgraduate supervision.
Whats in it for you?
The CSIR Offers
- Flexible hybrid work arrangement;
- Learning and development opportunities.
- Competitive and market-related remuneration packages.
- Total guaranteed salary packages which encompass contributions to the pension fund, risk insurance and medical scheme.
- We openly acknowledge and reward our employees' contributions and accomplishments through our esteemed CSIR Excellence Awards.
PLEASE NOTE THAT FEEDBACK WILL BE GIVEN TO SHORTLISTED CANDIDATES ONLY.
For more info, please email us at Please
do-not
send your applications to this mailbox, it is only for enquiries.
The CSIR is an equal opportunity employer. As such, it is committed to the employment Equity Act and will through the filling of this vacancy, give preference to candidates from designated groups in terms of the Employment Equity Act. By applying for this position at the CSIR, the applicant understands, and agrees that the CSIR may solicit a credit and criminal report from registered credit bureau and/or South African Police Services (in relation to positions that requires trust and honesty and/or entail the handling of cash or finances), and may also verify the applicants educational qualification and employment history.
The CSIR reserves the right to remove the advertisement at any time before the stated closing date and it further reserves the right not to appoint if a suitable candidate is not identified. **
Clinical Research Nurse
Posted today
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Job Description
The Research Professional Nurse functions under the supervision of the Study Coordinator to assist in the maintenance of the integrity of the study goals through the recruitment and care of the clinical trial participants, collection of specimens and data.
- 4-year Degree / Diploma in Nursing
- At least one to two years' experience working in the clinical and/or research sector
- Interpersonal skills
- Decision making and problem-solving skills
- Good record keeping skills
- Fluency in English and isiZulu/Afrikaans/Xhosa
- Good Communication skills
- Familiarity with the Pretoria region
- Working knowledge of Good Clinical Practice (GCP) and the Protection of Human Participants in Research (HSP)
- Professional registration or license requirements Registration with the South African Nursing Council (SANC)
- Participant Recruitment and Consenting / Assenting
- Participant Management
- Data Collection
- Phlebotomy and management of drip lounge patients (putting up drips and monitoring patients)
clinical research associate
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Job Description
Clinical Research Associate - Johannesburg
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 2 years of experience as a Clinical Research Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our
careers site
to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Research Associate
Posted today
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Job Description
Job Title: Clinical Research Associate (CRA)
Location: Cape Town, South Africa
Company: ICON Strategic Solutions – FSP
As a Clinical Research Associate, Your Primary Focus Will Be On The End-to-end Management Of Clinical Trials At Assigned Study Sites. You Will
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.
We're Searching For a Highly Motivated Individual With
- A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
- University degree in Health Science, or a related field.
- To be based in Cape Town.
- Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
- Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
- Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON:
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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clinical research associate
Posted today
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Job Description
Clinical Research Associate - Johannesburg
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What You Will Be Doing
- Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
- Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
- Collaborating with investigators and site staff to facilitate smooth study conduct.
- Performing data review and resolution of queries to maintain high-quality clinical data.
- Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 2 years of experience as a Clinical Research Associate.
- In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
- Strong organizational and communication skills, with attention to detail.
- Ability to work independently and collaboratively in a fast-paced environment.
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Clinical Research Associate
Posted today
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Job Description
CAPRISA is an award-winning global research organisation located on the campus of the Nelson R Mandela School of Medicine in Durban, South Africa and undertakes research in HIV, TB and Covid at four clinical research sites in KwaZulu-Natal. CAPRISA's goal is to undertake globally relevant and locally responsive research that contributes to understanding HIV Vaccines and Pathogenesis, Prevention and Epidemiology, the links between Tuberculosis and AIDS treatment and Covid-19. CAPRISA is a UNAIDS Collaborating Centre for HIV Research and Policy and is recognised as a DSI-NRF Centre of Excellence in HIV Prevention and hosts the SAMRC HIV-TB Pathogenesis and Treatment Research Unit.
The successful incumbent will join the CAPRISA Gates Foundation Vaginal Microbiome Clinical Trials Unit (VM-CTU) and will be based at the CAPRISA Headquarters in Durban.
Minimum Requirements- A bachelor's degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent).
- At least 2–3 years of experience monitoring clinical trials with knowledge of clinical trials operations, preferably early-phase (Phase I/II) studies.
- Solid knowledge of SA GCP guidelines, ICH-GCP guidelines, South African Ethics in Health Research Guidelines, SAHPRA and international regulatory requirements.
- Prior experience in monitoring and/or trial coordination, within an academic or as a CRA in industry-sponsored trial setting.
- Strong understanding of investigational product accountability, safety reporting, and protocol compliance.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with electronic data capture (EDC) systems.
- Experience working within a multidisciplinary research environment is an advantage.
Requisition::General Details::Comptenecies
Duties & Responsibilities
- Assume the role of regional monitor for all trials conducted in the VM-CTU for an estimated 5 trials per annum.
- Develop and maintain Standard Operating Procedures relevant to the portfolio.
- Create trial monitoring plans in conjunction with the trial sponsor representatives.
- Conduct study initiation visits for each new trial protocol to assess site readiness for study activation.
- Conduct trial monitoring (clinic, laboratory and pharmacy) to ensure compliance with study protocols, SOPs, ICH-GCP, and local regulatory requirements.
- Review case report forms (CRFs), source documents, and data entry to verify accuracy, completeness, and timeliness.
- Monitor and track protocol deviations, adverse events (AEs/SAEs), and data queries.
- Review essential study documentation, including trial master file (eTMF) and investigator site file (eISF).
- Prepare monitoring reports, progress updates, and assist with audits and inspection preparation.
- Contribute to quality assurance initiatives and continuous improvement of trial conduct at the unit.
- Support close-out activities, ensuring data integrity and regulatory compliance are maintained throughout the trial lifecycle.
Clinical Research Associate
Posted today
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Job Description
Role Description
This is a full-time, on-site role for a Clinical Research Associate based in Durban. The Clinical Research Associate will oversee the daily operations of clinical trials, ensure compliance with protocols, and manage research activities. Responsibilities include coordinating with clinical trial sites, monitoring the progress of studies, and maintaining accurate documentation. The role involves close collaboration with other clinical research professionals to ensure the integrity and quality of the research data.
Responsibilities:
- Assume the role of regional monitor for all trials conducted in the VM-CTU for an estimated 5 trials per annum.
- Develop and maintain Standard Operating Procedures relevant to the portfolio.
- Create trial monitoring plans in conjunction with the trial sponsor representatives.
- Conduct study initiation visits for each new trial protocol to assess site readiness for study activation.
- Conduct trial monitoring (clinic, laboratory and pharmacy) to ensure compliance with study protocols, SOPs, ICH-GCP, and local regulatory requirements.
- Review case report forms (CRFs), source documents, and data entry to verify accuracy, completeness, and timeliness.
Qualifications
- A bachelor's degree in a health-related or life sciences discipline (e.g., Pharmacy, Nursing, Medical Sciences, Clinical Research, or equivalent).
- At least 2–3 years of experience monitoring clinical trials with knowledge of clinical trials operations, preferably early-phase (Phase I/II) studies.
- Solid knowledge of SA GCP guidelines, ICH-GCP guidelines, South African Ethics in Health Research Guidelines, SAHPRA and international regulatory requirements.
- Prior experience in monitoring and/or trial coordination, within an academic or as a CRA in industry-sponsored trial setting.
- Strong understanding of investigational product accountability, safety reporting, and protocol compliance.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and familiarity with electronic data capture (EDC) systems.
- Experience working within a multidisciplinary research environment is an advantage.