Clinical Research Associate

16 hours ago

Johannesburg, South Africa ICON Full time

As a CRA, sponsor dedicated in Johannesburg, you will play a key role in the success of our clinical trials by overseeing site activities, ensuring compliance with protocols, and contributing to the timely delivery of our studies.

As a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:

- Independently monitor multiple Phase clinical trial sites, across different therapeutic areas.
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.

**Experience and Qualifications required**:

- A minimum of 2 years in the capacity of Clinical Research Associate, independently monitoring Clinical Trials on-site.
- Relevant Bachelor’s Degree with relevant healthcare experience in the pharmaceutical or clinical research industry
- The role and sites are predominantly Johannesburg based, therefore it is a requirement to be residing in Johannesburg.
- Strong therapeutic and protocol knowledge as provided in company training.
- Proficiency with medical terminology.
- Working knowledge of Local Regulations.
- A demonstrated working knowledge of ICH/GCP Guidelines.
- Excellent record-keeping skills and attention to detail.
- Experience conducting independent Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
- Fluent in English, both written and oral.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Strong technical skills with CTMS, eCRF, eTMF

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance

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