CRA I

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

For our client in the Antwerp region, we are looking for a Clinical Research Associate (Site Manager) to join our ICON team! You will be working for one of the most attractive employers in Belgium, creating a real impact on the health of patients worldwide.

As a CRA your main responsibilities will be to provide trial coordination and site management services for your assigned studies/sites. For this you will independently ensure that your sites are inspection read at all times, perform pretrial assessment,site selection, subject recruitment and retention planning, site initiation, monitoring and close-out.

Key responsibilities

• Perform site qualification, site initiation, and closeout visits, ensuring regulatory and protocol compliance. Visits may be on-site or remote.
• Generate queries and manage resolutions with site personnel.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required study documents as per SOPs and Study Monitoring Plan.
• Perform investigational product accountability as per the protocol and Study Monitoring Plan.
• Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
• Act as primary liaison with site personnel.
• Management and collection of site's study regulatory documents.
• Enter data into tracking systems as required.
• Assist and support audit preparation and CAPA implementation.
• AE/SAE and expedited reporting and management.

Requirements

• Degree in a health or sciences related field
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Proven experience in on-site monitoring of clinical studies is a must. 
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus.
• Proven ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.
• Fluently Dutch, French and English

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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.