Clinical Research Associate (Healthcare 2 year FTC Renewable)

Ajpersonnel; Durban; On-site; ZAR 400,000 - 600,000; Full time

Job summary

A clinical research organization in Durban seeks a Regional Monitor to oversee clinical trials. The role involves ensuring compliance with regulations and preparing monitoring reports. Candidates must have a Bachelor's degree in a health-related field and extensive experience in clinical trial monitoring. This is a 2-year fixed-term contract with the possibility of renewal.

Qualifications

• 23 years of experience in monitoring clinical trials.
• Solid knowledge of SA GCP guidelines and ICH-GCP guidelines.
• Experience working within a multidisciplinary research environment.

Responsibilities

• Assume the role of regional monitor for all trials.
• Conduct trial monitoring to ensure compliance.
• Prepare monitoring reports and assist with audits.

Skills

Clinical trial monitoring

Regulatory compliance

Standard Operating Procedures

Data integrity

Communication skills

Education

Bachelors Degree in health-related or life sciences

Tools

Word

Excel

PowerPoint

Outlook

Electronic data capture systems

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