28 Research Studies jobs in South Africa

Study Coordinator

Cape Town, Western Cape University of Cape Town Lung Institute

Posted 5 days ago

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Job Description

Minimum Requirements:
  • Certificate / Degree / Diploma in General Nursing or Clinical Technology or another medical field
  • 2 - 5 years experience in clinical research on multiple projects
  • Good Clinical Practice Certification (advantageous)
  • Keen interest in Research (particularly Allergy, Immunology and Dermatology)
  • Computer Literacy (proficiency in Microsoft Office and electronic Data Management systems, email, internet)
  • Valid Drivers License (essential)
  • Fluency in English and a second language (Afrikaans and / or isiXhosa)
  • Good interpersonal, communication and time management skills
  • Excellent organisational skills
Responsibilities include (but not limited to):
  • Screen participants for inclusion into studies using specified inclusion criteria
  • Scheduling of participants for clinical examination and follow up (telephone and community visits)
  • Perform all delegated study procedures, i.e. vital signs, electrocardiographys (ECGs), collect laboratory and pharmacokinetic (PK) biological specimens
  • Prepare laboratory specimens for shipping or transporting to laboratory
  • Management of participant records: maintain, retrieve and file according to study visits. This includes laboratory and procedure results
  • Maintain applicable study logs (screening, enrolment, participant confidential identification log, AE tracking, etc.)
  • Oversee all trial related activities for sites at both UCT Lung institute and Tertiary Cape hospitals where the unit operations
  • Management / Co-ordination of study participants
  • Interface with non-study routine clinical and nursing staff in hospitals
  • Assist in drafting and updating of SOPs
  • Study-related data capture and management
  • Perform phlebotomy procedures and insertion of peripheral IV lines (if a nursing applicant)
Additional Information:
  • Position will be based in Mowbray
  • Contract Based
  • Working hours: 40 hours per week, Monday to Friday.
This is an open-ended advertisement, as we seek to establish a comprehensive database of potential candidates.
We look forward to receiving your application and considering you for the potential Study Coordinator role within our organization.

EMPLOYMENT EQUITY STATEMENT
The University of Cape Town Lung Institute is committed to equity in our employment practices and reserves the right not to appoint.
The selection process will be guided by the Employment Equity Plan and Targets of the University of Cape Town Lung Institute (Pty) Ltd.

POPIA STATEMENT
Please note that when applying for any position, reference checks will be completed, and personal information defined in the protection of personal information Act 4 of 2013 will be processed. In applying for this position, applicants will be deemed to have consented to such processing as defined in the policy statement

*Please Note: This Position is not on UCT Conditions of Service.
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Study Coordinator

Brooklyn, Gauteng R250000 - R450000 Y Task Applied Science

Posted today

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Job Description

About the Company:

TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.

Overall Purpose of the Position:

A study coordinator plays a pivotal role in the execution and management of clinical trials conducted at the research site. The position needs to acquire in-depth knowledge of relevant study protocols and will be responsible for coordinating various aspects of the clinical trial process to ensure compliance with regulatory standards, protocol requirements, and quality standards across the major aspects of clinical research including study management, data collection, participant care, participant advocacy and recruitment. This role demands meticulous attention to detail, excellent organizational skills, and effective communication abilities to facilitate seamless collaboration among research team members, sponsors, and participants. Specific duties and requirements may vary depending on the study protocol and site structure.

Key Performance Areas (KPAs) & Responsibilities include, but not limited to:

Protocol adherence:

  • Ensuring strict adherence to study protocols, regulatory guidelines, ethical and good clinical practice guidelines as well as TASK standard operating procedures (SOPs) whilst ensuring participant safety throughout the conduct of the clinical trial
  • Assisting (Deputy/Assistant) Site Manager in preparing for study setup/start

Participant Recruitment and Screening:

  • Collaborating with the recruitment team to set up recruitment plan and identify potential participants according to study eligibility criteria.
  • Screening of potential participants according protocol guidelines and eligibility criteria.
  • Maintaining accurate participant records and ensuring informed consent procedures are followed.

Study Documentation:

  • Performing the preparation, maintenance, quality checks and completion of study documentation, including source and case report forms (CRFs), and study logs.
  • Maintaining accurate study documentation according to good clinical practice (GCP) and ensuring compliance with regulatory requirements and ethical guidelines.
  • Performing electronic data capturing and validation.
  • Preparing, coordinating, and facilitating audits and inspections.

Clinical Trial Conduct:

  • Assisting the investigators in all aspects of study management and according to delegation and training.
  • Coordinating, tracking and performing clinical trial activities, including scheduling study preparation, set-up and readiness, participant visits, performing study procedures according to scope, relevant compliancy checks, quality and timely data collection and entry.
  • Maintaining an adequate supply of study laboratory kits and consumables and supporting sample processing staff in various functions such as processing and shipping samples, while ensuring good documentation practises.
  • Educating participants on study related requirements and compliance.
  • Familiarising themselves with terminology (protocol and medical), normal ranges applying to procedures to be able to identify and report values and observations that fall out of normal range.
  • Maintaining accurate and complete records of protocol deviations and share regularly with Principal Investigator and Assistant Site Manager.
  • Ensuring Investigator Site Files are updated and maintained continuously with up to date and complete study and essential documentation.
  • Overseeing quality control for the specific study to ensure data integrity, protocol compliance and completion.

Communication and Collaboration:

  • Serving as the primary point of study contact for communication between sponsor, sponsor representative and other internal and external stakeholders.
  • Attending to and facilitating meetings to review progress, address challenges, and implement corrective actions as needed.

Quality Assurance:

  • Working with the quality teams to implement quality control measures to ensure data integrity, protocol compliance, and participant safety throughout the study.
  • Implementing internal Quality assurance measures to ensure GCP compliance, quality data collection and participant safety.
  • Conducting regular quality checks and addressing deviations or discrepancies promptly.
  • Addressing and responding to queries from sponsor representatives in an effective and timely manner.

Training and Development:

  • Acquiring and completing protocol specific training and assisting investigators by coordinating training to the rest of the study team in a timely manner.
  • Staying up to date on relevant guidelines, regulations, and industry trends through continuous education and training.

General:

  • Assisting with and performs all duties with-in reasonable scope.

Ideal Requirements

  • Nursing tertiary Diploma or bachelor's degree (Professional Nurse)
  • Valid SANC certificate
  • Previous experience in clinical trials, preferably in a coordinator or similar role.
  • Strong understanding of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.
  • Professional use of the English language: both written and verbal.
  • Strong administrative skills.
  • Proficient in utilising various software systems, including clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant applications.
  • Computer literacy – Ability to use Word, PowerPoint and Excel at intermediate level.
  • Flexibility to work at other TASK sites and to accommodate occasional night and weekend work (TASK Brooklyn Primary site).

Key Personal Inherent Characteristics

  • Excellent organizational skills with the ability to prioritize tasks and manage multiple responsibilities simultaneously.
  • Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders.
  • Attention to detail and a commitment to maintaining high standards of quality and compliance.
  • Functions well independently as well as in a team.
  • Initiative.
  • Self-driven.

Details:

Area: Brooklyn, Cape Town

Contract Type: 12 Months Fixed Term

Applications Close: 15 August 2025 (16:00)

If you have not received a response within one month, your application was most likely unsuccessful.

TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.

Meeting our employment equity goals will be acknowledged during the recruitment process

Job Types: Full-time, Temporary

Contract length: 12 months

Application Question(s):

  • What are your monthly gross salary expectations (before deductions)?
  • Where is your notice period?
  • Do you have a Nursing qualification (Professional Nurse)?
  • Do you have a valid SANC certificate?

Work Location: In person

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STUDY COORDINATOR

Desmond Tutu Health Foundation

Posted 6 days ago

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Job Description

contract

STUDY COORDINATOR


TWELVE (12) MONTHS FIXED-TERM CONTRACT


MASIPHUMELELE; MPILO HEALTH PARK



The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organization focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa. 


We have fantastic job opportunities across our businesses for talented people wanting to realize their full potential. Could that be you? If so, we invite you to explore the possibility of joining us to play your part in Desmond Tutu Health Foundations’ exciting future.


The main purpose of this position is to implement study protocols and Standard Operating Procedures (SOPs) on site at the Masiphumelele Clinical Research Site and Mpilo Health Park.



  • Health/ Science Tertiary Degree related qualification

  • Minimum of two years of experience in clinical research

  • Experience working on adolescent studies

  • Fluent in isiXhosa

  • Attention to detail

  • Ability to solve problems

  • Proficiency in MS Office (Word, Excel, PowerPoint, and Internet)

  • Excellent communications skills (verbal and written)

  • Planning and organizing skills

  • Strong problem-solving skills

  • Strong decision-making skills

  • Attention to detail

  • Ability to work independently and as part of a team

  • Ability to work under pressure


Advantageous:



  • Project management experience

  • Knowledge of HIV/ TB/ STI’s

  • Experience working on mental health studies

  • Experience of working in community-based environment

  • Valid Good Clinical Practice (GCP) Certificate 


Responsibilities:



  • Mental health study Management



  • The successful implementation and execution of mental health studies, protocols and SOPs to ensure smooth and successful running of studies from start up to archiving

  • Responsible for staff training (including documentation) and oversight, data collection, and other administrative tasks Managing regulatory submissions

  • Ensure that QC/ QA processes are followed



  • Qualitative data collection, coding and analysis 



  • Conduct qualitative interviews, focus groups and participatory workshops with participants

  • Assist with coding analysis and dissemination of qualitative data



  • Communication



  • Maintain a positive relationship between site staff, between staff and participants and staff and any external stakeholders

  • Report regularly to PI and Site Lead and keep them updated on study-related issues and challenges

  • Administrative and academic support

  • Assist PI with literature reviews, presentations and other research tasks

  • Perform administrative duties related to study procurement, pay


Values fit:  Passion Innovation Progress Integrity Respect Excellence


Submit a detailed cover letter, updated CV with certified copy of highest qualification and details of two (2) current contactable referees by 10 October 2025. Incomplete applications will not be considered.


If you are a foreign national applying for this position, please attach a copy of your work permit to your application.


Only short-listed candidates will be contacted.


If you have not heard from us within four weeks after the closing date, please consider your application as unsuccessful.


We are committed to equity in our employment practices. It is our intention to appoint individuals with the aim of meeting our equity objectives. We reserve the right not to appoint if no suitable candidates are identified.


I understand and accept that by applying for this position, I authorized DTHF to process my personal information in accordance with its internal operational requirements.


I further understand that the personal information I disclose to DTHF will be processed in accordance with the requirements set out in the Protection of Personal Information Act and may include the transferring thereof to third parties for the purposes of verification.


This job may be removed before it expires.


Desmond Tutu Health Foundation is a child-friendly organisation committed to the protection of children.


For more information about the organization please visit our website.


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Data Analysis Lecturer

R150000 - R250000 Y EDUVOS

Posted today

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Job Advert Summary

Eduvos is looking to hire the services of an Independent Contractor, Data Analysis Lecturer, at our Durban campus on a part-time basis.

Type of appointment:

Independent Contractor (part-time; flexible workhours agreement)

Purpose:

  • To lecture Data Analysis-related modules, in the Law faculty on a part-time (contractual) basis.
  • To assist in the administration and departmental affairs and activities as required by the academic department.
Minimum Requirements

Minimum qualifications required:

  • Honours degree in Statistics/ Data Science / Mathematics/ Computer Science/ Information Systems or a relevant qualification (A Masters qualification will be an advantage)

Experience:

  • Minimum: 1 - 2 years relevant lecturing experience
  • Necessary knowledge of higher education practices and processes
  • Relevant research experience
Duties and Responsibilities

Modules to be lectured:

  • Introduction to Data Analysis
  • Computer Skills (All Levels)

Responsibilities:

  • Lecturing
  • General administration
  • Setting and marking of assessments
  • Preparation of notes and additional study materials
  • Quality Assurance
  • Management of At-risk students
Functional and Behavioural Competencies

Competencies

  • Initiative and responsibility
  • Constructive teamwork, relations and networking
  • Influence
  • Analysis and judgement
  • Innovation and change
  • Systematic approach (planning and organising)
  • Steadiness (emotional tenacity)
  • Communication
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Data Analysis Lecturer

R150000 - R250000 Y Eduvos

Posted today

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Job Description

Eduvos
is looking to hire the services of an
Independent Contractor, Data Analysis Lecturer
,
at our
Durban
campus on a part-time basis.

Type Of Appointment
Independent Contractor (part-time; flexible workhours agreement)
Purpose

  • To lecture Data Analysis-related modules, in the Law faculty on a part-time (contractual) basis.
  • To assist in the administration and departmental affairs and activities as required by the academic department.
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Post-Doctoral Fellowships – Council for Scientific and Industrial Research (CSIR)

Cape Town, Western Cape MPOWIR Mentoring Physical Oceanography Women to Increase Retention

Posted 18 days ago

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Job Description

Post-Doctoral Fellowships – Council for Scientific and Industrial Research (CSIR)

The CSIR has three temporary opportunities for Post-Doctoral Fellowships in the Southern Ocean Carbon and Climate Observatory programme (SOCCO), within the Smart Places cluster, and hosted at the Marine Institute (Ma-Re), UCT. The purpose of the fellowships is to conduct research in line with three H2020 projects in which SOCCO is a partner. These positions are offered as a two-year contract with the possibility of extension for a third year. These opportunities are based in Rosebank, Cape Town.

  • Southern Ocean CO 2 and heat uptake : the future role of the Southern Ocean in influencing the rates of global warming depends critically on the sensitivity of its uptake and storage of heat and anthropogenic CO 2. This sensitivity is thought to be largely dependent on the response in the physics of the mixed layer and sea ice system to climate change. This fellowship aims to use air-sea CO 2 reconstructions, high resolution models as well as Earth System Models (ESM) to examine the climate sensitivity of the mechanisms that explain CO 2 and heat ocean-atmosphere fluxes in the Southern Ocean.
  • Southern Ocean emerging feedbacks in carbon cycle: the sensitivity of coupled ocean-atmosphere physical and ocean biogeochemical mechanisms to climate forcing can lead to regional non-linear responses that lead to changing feedbacks, thresholds of abrupt change and tipping pointes. This fellowship aims to use the South African ESM combination with other CMIP6 models to examine how non-linearities in the carbon cycle can be linked to specific physical and biogeochemical mechanisms, their scales and dynamics in the Southern Ocean.
  • Southern Ocean Biogeochemical model development: the sensitivity of the ocean biological carbon pump to climate forcing is critical to project changing carbon feedbacks in the second half of the 21 st century, particularly in the Southern Ocean. For this fellowship the successful candidate will be a biogeochemical modeller, who will be responsible for model development through improved parameterisations of physiological processes for phytoplankton in coupled biogeochemical-physical models. This will be done based on experience in parameterisations for functional responses to multiple drivers. Observational data will be collected under varying conditions that will be used to derive and implement new relationships into numerical models.
Key responsibilities
  • Initiate further independent research within the strategic objectives of the current programme;
  • Assist with Master’s and Doctoral supervision of students in support of the SOCCO/UCT-Ma-Re human capital development mission;
  • Lead, assist and supervise field data collection and model development;
  • Contribute to the writing of numerous reviewed journal publications, and be the lead author of at least two.
Qualifications, skills and experience
  • A Doctoral degree in Ocean CO 2 or biogeochemical modelling and/or observations, with experience in modelling;
  • Experience in acquiring and processing large global data sets as well as running and analysing model outputs;

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Clinical Research Associate

Pharmaceutical Research Associates, Inc

Posted 3 days ago

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Overview

Job Title: Clinical Research Associate (CRA) Location: Cape Town, South Africa

Company: ICON Strategic Solutions – FSP

Responsibilities

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.
Qualifications

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: 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. 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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#LI-Hybrid

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Clinical Research Associate

Medpace

Posted 4 days ago

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Job Summary

Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Monitoring team in South Africa. This position will work with a team to accomplish tasks and projects that are instrumental to the company’s success. The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the drug development process by providing unrivalled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you.

We kindly ask to submit applications in English.

Entry level associates with research associate or trial assistant-type backgrounds may also be considered.

Responsibilities
  • Conduct pre-study, initiation, monitoring, and closeout visits for research sites;
  • Perform source document verification and case report form review;
  • Perform regulatory document review;
  • Conduct study drug inventory;
  • Perform adverse event and serious adverse event reporting and follow-up;
  • Assess patient recruitment and retention.
Qualifications
  • Minimum a Bachelor of science in health-related field or equivalent
  • Minimum of 1-year independent clinical monitoring; Entry level associates may be considered with relevant trial assistant or research associate-type backgrounds
  • Broad knowledge of medical terminology and clinical patient management
  • Basic knowledge of drug therapy techniques and clinical research methodologies
  • Comprehensive knowledge of Local Regulations and ICH GCP
  • Excellent oral and written communication skills
  • Fluency in English
  • Great attention to detail
  • Must hold a valid driver’s license
Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

  • Flexible work environment
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives

Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO/AA Employer M/F/Disability/Vets

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Clinical Research Associate

R350000 - R550000 Y CAPRISA Careers

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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.
Competencies
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.
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Clinical Research Associate

R900000 - R1200000 Y Afrique Connection Consultancy

Posted today

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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.
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