Clinical Research Associate - (Healthcare - 2 year FTC - Renewable)
AJ PersonnelDurban, South Africa
5 days ago
Job description
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
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Clinical Associate • Durban, South Africa
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