Clinical Research Associate (Healthcare 2 year FTC Renewable)
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Job Location:
Durban - South Africa
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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:
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
- Bachelors Degree in a health-related or life sciences discipline (e.g. Pharmacy Nursing Medical Sciences Clinical Research or equivalent)
- At least 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
- 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
- Proficient in Word Excel PowerPoint Outlook and familiar with electronic data capture (EDC) systems
- Experience working within a multidisciplinary research environment is advantageous
- 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
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- Please take note that the applicants who do not adhere to the minimum requirements will not be considered for the respective position
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- 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
About Company
AJ Personnel offers expert recruitment services and job vacancies across South Africa. Trusted among top recruitment agencies for connecting talent with opportunity.
