Clinical Research Associate II
- Belgium
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
As a Clinical Research Associate (Site Monitor) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Our sponsor is a global biopharmaceutical company, located in the Brussels region. They are focussed on Breakthroughs That Change Patients’ Lives and have developed some of the world’s most impactful medicines and vaccines.
Hence, their clinical research is focussed on the therapeutic area's of rare diseases, internal medicines, anti-infectives, vaccines... For this opportunity they are looking for an experienced clinical research monitor with extended experience in oncology.
- 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.
Our ideal candidate will have following background and skills:
- Degree in life sciences, pharmacy preferred.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Proven experience in on-site monitoring of clinical studies is a must
- Experience in Oncology
- 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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
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Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
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Summary
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A Day In The LifeContent type
BlogsPublish date
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Summary
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by
Suzaita Hipolito
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