SMA II

As a Clinical Research Coordinator (SMAII) located in the area Eindhoven you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Entry of data into Clinical Trial Management Software (CTMS). 
• Generation of reports in CTMS. 
• Assist Clinical Research Associates with the following clinical study related activities including but not limited to: 
• Support Institutional Review Board submissions / document prep and correspondence (initial, amendments, renewals). 
• Support site / study training. 
• Assist in preparation of site training / study initiation materials. 
• Create and maintain study binders. 
• Contact and coordinate study participant recruitment and enrollment for internal trials, including: 
• Retain documentation necessary for this process. 
• Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings, including locating participants, securing meeting locations, developing trial procedures, and designing survey materials. 
• Conduct quality audits through monitoring internally and externally (remotely or onsite) to ensure compliance with US or international regulations. 
• Maintain traceability and accountability of study devices. 
• Follow procedures to order study equipment. 
• Assist with device labeling, modified product process, set-up and shipments. 
• Manager return and disposition of study equipment. 
• Manager (generate and track) Purchase Orders (PO’s) to facilitate study payments to sites and vendors. 
• Data Entry and Validation. 
• User Assessment Testing (UAT) of Electronic Data Capture (EDC) system develop Excel spreadsheets for data capture validate / audit per validation plan. 
• Initiate and track requests for legal agreements. 
• Support the timely and accurate compilation of: all study data, study reports, including SAP file / document entries. 
• Maintain professional relationships with internal associates. 

Qualifications:

• BA or BS in biological sciences or related field, or RN or if no degree 5+ years’ experience as a clinical research coordinator. 
• Work experience in life science or medically related field. 
• Prior experience providing administrative support in a clinical trial or data management setting. 
• Awareness and working knowledge of applicable clinical research regulatory requirements ie, good clinical practice (GCP) and International Conference on Harmonisation (ICH) guidelines preferred. 
• Knowledge and experience in budgeting, accounting and contracting is preferred. 
• Self-motivated individual able to manage multiple tasks and priorities in an efficient manner. 
• Can work independently without direct supervision as well as in a team environment. 
• Ability to work according to standard operating procedures. 
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. 
• Strong written and verbal communication skills in English. 
• Effective time management, planning and organizational skills. 
• Attention to detail and accuracy in work. 
• Strong problem-solving skills and proactive attitude. 
• 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/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, colour, 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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