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Clinical Research Associate (Healthcare 2 year FTC Renewable)

AjpersonnelDurban, KwaZulu-Natal, South Africa

18 days ago

Job description

Background

Our client is an award-winning global clinical research organisation in the Durban area
They undertake research in HIV TB and Covid

Contract Period : 2 Year Fixed Term Contract - Renewable)

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

Minimum Requirements :

Bachelors Degree in a health-related or life sciences discipline (e.g. Pharmacy Nursing Medical Sciences Clinical Research or equivalent)

23 years 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

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

Proficient in Word Excel PowerPoint Outlook and familiar with electronic data capture (EDC) systems

Experience working within a multidisciplinary research environment is advantageous

TO APPLY :

Only if you meet the minimum job requirements and experience as mentioned above you may submit a detailed updated CV

Please Apply Online and complete your registration via our website to enable and protect you as a candidate and to accept the new POPIA terms and conditions

This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL

However you may remove your profile from AJ PERSONNEL when you are no longer in the job market

Please take note that the applicants who do not adhere to the minimum requirements will not be considered for the respective position

Note our clients may expire jobs at their own discretion

AJ PERSONNEL will only respond to shortlisted candidates

If you have not received a response within two (2) weeks from applying your application was then unsuccessful for that specific position however your profile remains on our system for future opportunities

Closing Date : 10 October 2025

Note : No CV will be accepted after the closing date

Required Experience : IC

Key Skills

CSS

Cloud Computing

Health Education

Actuary

Building Electrician

Employment Type : Contract

Experience : years

Vacancy : 1

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Clinical Associate • Durban, KwaZulu-Natal, South Africa

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