Senior CRA

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.

We are looking for an experienced CRA based in the Netherlands.

Responsibilities:

• Ensure the clinical studies are conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
• Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
• Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
• Attend all required meetings and provide updates to team.
• Support EDC user acceptance testing and training as applicable
• Oversee and support the creation of the trial master file, regulatory
• binder, source documents, and investigational product ordering,
• shipping, and associated documentation

Skills and experience

•  Bachelor or Masters in Science or Healthcare discipline Approximately
•  5 years related experience in clinical studies (healthcare setting ,
•  CRO, medical device and/or pharmaceutical company and/or industry) At least 3 years of experience as a Clinical Research Associate monitoring clinical studies[D1] .
• Experience in using EDC and CTMS systems is desirable Knowledge of
•  Sharepoint and Excel is helpful in this role Experience with direct
•  line management of staff including hiring, training, oversight and
•  mentoring[D2] Good command of written and spoken English language
•  Excellent verbal and written communications skills Excellent
•  interpersonal and organizational skills A pro-active, committed and
•  motivated attitude A demonstrated working knowledge of GCP, ICH
•  guidelines, ISO Standards, FDA/EU regulations Ability to work very
•  accurate and thorough Excellent record-keeping skills; good
• documentation practice Ability to maintain excellent working
•  relationships with a broad range of clinical study staff.
• Ability to work well in a team environment but also independently
• without significant oversight Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
• Flexibility in work hours and readiness to travel.
• Fluently in Dutch 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/benefitsAt 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-accommodationsInterested 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.