Clinical Research Associate

3 weeks ago

Johannesburg, South Africa ICON Full time

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

ICON South Africa is seeking an experienced CRA in Gauteng, to join one of our largest embedded sponsor programs. You will have the support of a local monitoring team as well as a highly tenured Senior Management team who are always supporting internal progression opportunities.

As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. You will be fully integrated into the client's systems, using their SOPs.
- The team is highly structured and functions are very specialized, allowing you to focus solely on producing quality monitoring, building relationships with sites and taking ownership of site management
- There is a strong pipeline of studies and you will have the opportunity to monitor groundbreaking trials and work in a dynamic environment which promotes learning and versatility
- Access to advanced technologies is provided. This streamlines processes allowing you to work more efficiently
- You will be part of a team which has seen huge growth across South Africa across varied therapeutic areas
- You will be joining a well-renowned sponsor program
- There is a strong and passionate ICON leadership team who take a hands on approach and you will be encouraged to participate and share your ideas. The management team are supportive of career development and you will have access to external training opportunities and pathways of development

**Responsibilities**:

- You will independently monitor multiple Phase clinical trial sites, across different therapeutic areas.
- You will utilize your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
- You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
- You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
- As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
- Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.

**Requirements**:

- A **minimum** of 12 months of independent on-site monitoring experience.
- Relevant Bachelor’s Degree (or equivalent) with 3 years of relevant healthcare experience in the pharmaceutical or clinical research industry.
- 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 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
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discri

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