8 Nov 2016

Clinical Research Associate

Covance – Posted by Agata MastalerzCape Town, Western Cape, South Africa

NOTE: This job listing has expired and may no longer be relevant!

Job Description

As CRA you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.


• Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor
• Completing Serious Adverse Event (SAE) reporting, processing production of reports
• Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned
• Assisting with training, mentoring, and development of new employees, e.g. co-monitoring

Required skills, experience:

• Basic understanding of the clinical trial process
• Minimum two years of relevant clinical research experience in pharmaceutical or CRO industries
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Thorough knowledge of monitoring procedures

Required education:

• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• Fluency in English language

In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.

How to Apply


Job Categories: Pharmaceutical. Job Types: Full-Time. Job Tags: Clinical Research Associate, clinical trials, and CRA.

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