16 Clinical Coordinator jobs in South Africa
Clinical Coordinator – Lay Advisor Programme
Posted today
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Job Description
Clinical Coordinator – Lay Advisor Programme
Voluntary Leadership Position with Stipend
Position Overview
Job Title:
Clinical Coordinator – Lay Advisor Programme
Reports to:
Chairperson, MNDA South Africa
Employment Type:
Voluntary position with a monthly stipend and allowances
Location:
Hybrid (remote/home-based with national travel as required)
Time Commitment:
8–12 hours per week (flexible)
About This Opportunity
At MNDA South Africa, we believe that every person living with Motor Neurone Disease deserves dignity, compassion, and care that truly sees them. As
Clinical Coordinator
, you will assume a vital leadership role, guiding and supporting our network of Lay Advisors who walk alongside families through some of their most challenging times.
This is more than coordination; it's about weaving together a community of care, strengthening connections across provinces, and ensuring that no person or family feels alone on this journey. Your contribution will help us sustain excellence, compassion, and accountability in everything we do.
Key Responsibilities
Programme Leadership & Coordination
- Lead and coordinate the national Lay Advisor Programme in line with MNDA SA's Advisor Guidelines and Processes.
- Ensure timely and consistent delivery of first visits, follow-ups, urgent visits, and monthly support groups.
- Safeguard quality and accountability across all provinces.
Advisor Support & Development
- Mentor, guide, and support Lay Advisors in their daily work.
- Encourage healthy professional boundaries and protect against burnout.
- Foster knowledge sharing and collective learning across the advisor network.
- Model and uphold MNDA SA's values of
Ubuntu, dignity, and patient-centred care
.
Quality Assurance & Compliance
- Review Patient Detail Forms, claims, and monthly reports for accuracy and completeness.
- Ensure all programme activities meet established protocols and quality standards.
- Maintain reliable records and reporting systems.
Strategic Partnerships & Networking
- Build strong referral pathways with neurologists, hospitals, and healthcare providers.
- Represent MNDA SA at healthcare and community forums.
- Contribute to the growth and improvement of the Lay Advisor Programme.
Equipment & Resource Management
- Oversee the loan equipment programme, ensuring fair access, responsible use, and proper return processes.
- Coordinate resources and support across provinces based on identified needs.
Essential Requirements
Professional Background
- Qualification or experience in clinical, allied health, or social work (preferred).
- Understanding of chronic illness and palliative care principles.
- Experience in coordination, leadership, or programme management (advantageous).
Core Competencies
- Leadership Excellence:
Ability to guide, inspire, and coordinate dispersed teams. - Communication Skills:
Clear, compassionate, and confident in both writing and speaking. - Organisational Expertise:
Strong administrative and project management skills. - Emotional Intelligence:
Empathetic, patient-focused, and culturally sensitive. - Adaptability:
Able to thrive in a voluntary sector environment with diverse needs.
Personal Attributes
- Collaborative and community-minded, with initiative to work independently.
- Aligned with MNDA SA's mission and values.
- Resilient and emotionally mature, able to engage with life-limiting conditions.
- Flexible and willing to travel when needed.
What We Offer
Financial Support
- Monthly stipend as recognition for your time and expertise.
- Reimbursement for travel, telecommunications, and administration costs in line with MNDA SA policy.
Professional Development
- Training and learning opportunities.
- Access to national and international MND networks.
- Recognition within the healthcare and voluntary sectors.
Personal Rewards
- The opportunity to make a profound difference in the lives of people living with MND and their families.
- Being part of a passionate, supportive team working to build South Africa's leading MND support network.
- The reward of knowing your work strengthens dignity, compassion, and hope where it matters most.
Application Process
If you are a committed professional who shares our vision of dignity and support for people living with MND, we would love to hear from you.
Contact to discuss this opportunity or submit your application.
MNDA South Africa is committed to equality, diversity, and inclusion. We warmly welcome applications from all qualified candidates, regardless of race, gender, age, religion, sexual orientation, or disability status.
Clinical Data Coordinator
Posted today
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Job Description
Remote Clinical Data Coordinator | Home Healthcare Operations
Own the data that drives patient care—right from your home.
We're a home healthcare company that relies on precision, speed, and reliability to keep operations running and patients receiving timely, high-quality care. We're seeking a
Clinical Data Coordinator
to manage reporting, case assignments, and nurse scheduling end-to-end. This isn't a junior role—it's a
Level 3 autonomous specialist position
designed for someone who thrives on accuracy, takes initiative, and builds systems that eliminate errors and delays.
If you're detail-driven, proactive, and ready to be the operational backbone for a growing healthcare team, this role is for you.
What You'll Do
- Own the Google Sheets coordination system: no missed assignments, no broken IDs, no delays.
- Batch-assign
60–80+ cases per week
by region and language; maintain master databases and nurse sheets. - Field and resolve nurse issues, respond to insurer emails, and keep status updates moving without bottlenecks.
- Produce repeatable weekly reports (utilization, census, overtime, department snapshots) that managers can trust.
- Export from HG/HAXchange, clean and structure data in Sheets/Excel, and deliver manager-ready reports.
- Maintain data dictionaries, SOPs, and reporting standards so cycles run in hours, not days.
- Spot anomalies early, flag them clearly, and partner with managers to refine workflows.
- Reduce rework and drive process improvements across reporting and coordination.
Must-Have Skills
- Advanced expertise in
Excel/Google Sheets
: VLOOKUP, XLOOKUP, INDEX/MATCH, PivotTables, filters, validation, and conditional logic. - Precision and ownership in managing IDs, mappings, and version control.
- Strong written and verbal English;
bilingual Spanish/English highly preferred
. - Confidence in healthcare operations or similar high-stakes environments.
- Clear communicator who can translate data issues for non-technical stakeholders.
Nice to Have
- Familiarity with
HG/HAXchange
. - Experience in
healthcare coordination or billing
.
Why This Role Matters
Nurses can't succeed without the right data, assignments, and reporting—and you'll be the one ensuring they have it. By running coordination and reporting with precision, you'll reduce errors, speed up cycles, and directly impact the quality of care patients receive.
This is a
full-time, remote position
where your expertise in data management, process improvement, and healthcare coordination will create stability and efficiency for a mission-driven team.
Ready to own the systems that power patient care? Apply now.
Clinical Care Coordinator
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Important Notice
Mediclinic wants to alert candidates that third parties are from time to time fraudulently advertising vacancies at Mediclinic and / or offering employment contracts with subsequent payment instructions to accounts linked to the fraudulent activity. Please note that Mediclinic will never request payment for an application or offer made. All official vacancies are advertised on the Mediclinic career website and candidates are advised to visit the site to confirm the validity of vacancies.
Clinical Care Coordinator
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ER24 Contact Centre 124 | Rivonia | South Africa
Closing date: 03/10/2025
Number of positions: 1
Recruiter name: Silindokuhle Bawuti
Reference number: 63208
Workplace Type: ((cust_WorkplaceType))
Permanent
Please note if you are an internal employee on a fixed term contract please apply using an external candidate profile and not your employee profile
MAIN PURPOSE OF JOB
The Clinical Care Coordinator will collaborate with various stakeholders, including; patients, healthcare providers, care teams, facilities, and schemes to ensure that all patients who qualify for care coordination are adequately cared for through the entire patient journey. They will be an advocate for their patients and ensure that the care team effectively coordinates patient care from request to post-discharge. They will also be responsible for monitoring and reviewing the patient's biometrics and immediate wellbeing with continuous record keeping on multiple electronic platforms.
KEY RESPONSIBILITY AREAS
- To optimise the patient experience by coordinating various care plans for several patients at once
- Reporting, analysis and feedback
- To provide tele-health support, review virtual patient wellbeing and ensure patient monitoring maintained within required clinical parameters
- Personal effectiveness
Required Education
ESSENTIAL EDUCATION
Degree / Diploma leading to qualification as a Professional or General Nurse
Diploma / Degree in relevant healthcare field
DESIRED EDUCATION
Post-graduate degree in clinical or healthcare management will be an advantage
Required Experience
ESSENTIAL MINIMUM EXPERIENCE
Qualified Paramedic/ Emergency Care Practitioner/ Professional Nurse with at least 3-years' prior experience working with patients in either an administrative, clinical or care coordination role
Desired Experience
Virtual care and/or home healthcare experience and chronic disease management would be an advantage
Required Job Skills And Knowledge
- Organisational skills
- Attention to Detail
- Knowledge of all relevant policies and procedures
- Working knowledge of the local and international healthcare market
- Computer literacy (MS Office)
- Excellent communication, feedback, and follow-up skills (English written and verbal skills).
- Quality management principles
- Well-developed customer service skills
- Virtual Healthcare and Telemedicine
- Medical terminology
- Business acumen and commercial insight
All applicants will be considered, with the understanding that preference will be given in accordance with the Employment Equity Plan of Mediclinic Southern Africa, as well as internal applicants/employees that meet the minimum requirements.
Please note if you are an internal employee on a fixed term contract please apply using an external candidate profile and not your employee profile
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Clinical Project Coordinator, Biotech
Posted today
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Job Description
Job Overview
Support, with minimal supervision, the Project Leader (PL) and Clinical Project Manager (CPM) with project management activities to ensure all work is conducted in accordance with standard operating procedures (SOPs), policies and practices, good clinical practices (GCP), applicable regulatory requirements, and meets quality/timeline metrics. Ensure customer satisfaction is met in relation to assigned project/s.
Essential Functions
- Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and standard operating procedures (SOPs).
- Assist with periodic review/audit of files for accuracy and completeness.
- Assist with the coordination and tracking of all information, communications, documents, materials, and supplies for assigned projects.
- Manage study specific eTraining and oversee compliance.
- Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
- Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices.
- Organize and support project leader (PL) in managing internal study team and customer meetings.
- Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly.
- Support the preparation of presentation materials for meetings (internal/external) and project summary data.
- Support the coordination of project team and/or customer meetings including logistics and materials required.
- Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing etc.
- Establish and manage performance dashboards, analyze event triggers and alerts and determine appropriate follow up for PL or others to act upon.
- Monitor metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
- Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPs.
- Coordinate onboarding of new Key Members and system access.
- Assist in the training and orienting of more junior project support staff.
Qualifications
- Bachelor's Degree in life sciences or other related field required Req
- Requires good knowledge within a specific discipline typically gained through extensive work experience and/or education.
- 4 – 5 years' experience or equivalent combination of education, training, and experience.
- Knowledge of clinical trials - basic knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;
- Communication - strong written and verbal communication skills including good command of English language. Good communication and interpersonal skills.
- Problem solving - good problem solving skills.
- Quality - results and detail-oriented approach to work delivery and output. Good planning, time management, and prioritization skills. Attention to detail and accuracy in work.
- IT skills - good software and computer skills, including MS Office applications.
- Collaboration - ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Cross-collaboration - ability to work across geographies displaying high awareness and understanding of cultural differences.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
Junior Clinical Data Coordinator
Posted 5 days ago
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Job Description
Junior Clinical Data Coordinator
At Mango5, we believe in empowering people through innovation, precision, and care. We support global clinical research by ensuring that data is managed with accuracy, integrity, and speed — helping bring better treatments to market faster. As part of our team, you’ll play a vital role in ensuring the quality and reliability of clinical trial data while building a career in a growing, specialized field.
Key Responsibilities
- Manage incoming clinical research data across multiple worksheets, systems, and image files.
- Ensure accurate data entry and escalate issues appropriately.
- Apply critical thinking and discretion, particularly in relation to adverse events.
- Upload visit data within defined timelines.
- Review project data and deliver results to stakeholders promptly.
- Request and manage source data corrections as required.
- Enter/upload data into third-party platforms (e.g., EDC systems).
- Review and resolve data queries.
- Participate in database lock activities.
- Conduct regular quality checks of data for completeness, accuracy, and integrity (ALCOA+).
- Assist in the identification and reporting of potential adverse events.
- Maintain project documentation and the Trial Master File (TMF).
- Assist in the creation and maintenance of case report forms.
Qualifications:
- Matric certificate (minimum requirement).
- Bachelor’s degree in a life sciences-related field (Advantagouss).
- 1–2 years of clinical trial and data management experience.
- Knowledge of Good Clinical Practices (GCP).
- Experience with electronic data capture (EDC) systems (preferred).
- Strong skills in the use of technology, tools, operating systems, and software.
- Strong organizational skills with experience balancing priorities and resources.
- Strong attention to detail.
- Critical thinking and problem-solving skills.
- Ability to plan proactively, anticipate challenges, and operationalize solutions.
- Able to work thoughtfully and decisively, fostering an inclusive work environment.
- Clear criminal record.
- Clear credit record.
Working hours:
- 45-Hour work week with rotating shifts between 16:00 - 4:00 (Daylight savings)
- Rotating working days from Monday to Sunday to ensure consistent global support
- Dynamic holidays
Remuneration
- Basic salary: Market-Related
- Shift allowance
- Commission
Benefits
- Medical Insurance (after 3 months of employment)
- Access to our LMS Portal for continuous learning and development
- Emergency Assistance
If you meet the criteria but do not hear from us within two weeks, your profile will be kept on file for future opportunities.
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
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, 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.
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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.
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.