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Clinical Research Associate - (Healthcare - 2 year FTC - Renewable)

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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