Clinical Research Associate - Sponsor dedicated

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.

For our sponsor, a global oncology company that is discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide, we are looking for a Clinical Research Associate. We are open to consider different levels of experience, but you will have at the minimum one year of independent monitoring experience. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them

As an experienced Clinical Research Associate, your role will be varied and challenging, you will be responsible for 2-3 studies (depending the number of sites), throughout the Netherlands and will have an average of 6-8 visits/month (this might vary and is given as an indication!)

• The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
• May be assigned to CRA activities or start-up activities, depending on experience and project needs
• Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
• Identify gaps and areas for improvement and propose CAPA.
• Supports start-up and provides local expertise.
• The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.

Detailed responsibilities:

• Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets
• Provides protocol and related study training to assigned sites.
• Conducts monitoring (pre-study, initiation, routine monitoring and closeout) visit per monitoring plan and applicable SOPs
• Conducts co-monitoring visits, if required
• Completes monitoring visit reports
• Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
• Ensure inspection readiness of the study and sites
• Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Attends disease indication project specific training and general CRA training as required
• Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
• Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
• Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• Ideally 2-4 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English and Dutch (spoken and written)

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.

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