Clinical Research Associate

Location: South Africa, Home-based

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON South Africa is seeking experienced CRAs 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.

Why apply?

• 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 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.

• 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

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.