Ihcra

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 hiring a Clinical Trial Coordinator (CTA) within our Strategic Solutions team!

In this position, you will be working on an outsourced basis for our client situated in Haarlem. You will join a dynamic and engaging team of consultants, and you will have a dedicated line manager both at the client site and at ICON to support you throughout this journey.

Trial and Site administration:

• Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non‐clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request

Document Management:

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Assist with eTMF reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Execute eTMF Quality Control Plan
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities:

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments:

• Collaborate with finance/budgeting representatives for:
• Develop country and site budgets (including Split site budget)
• Tracking, and reporting of negotiations
• Maintenance of tracking tools
• Contract development, negotiation, approval and maintenance (e.g. CTRAs)
• Update and maintain contract templates (in cooperation with Legal Department)
• Payment calculation and execution (investigators, vendors, grants)
• Ensure compliance with financial procedures
• Monitor and track adherence and disclosures
• Budget closeout
• Obtain and process FCPA documentation in a timely manner

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor
• Contributes strongly to CTC team knowledge by acting as Subject Matter Expert
• Mentors / buddies junior CTCs on process requirements

You are:

• Eager to embark on your initial journey into clinical research
• Possessing a background in a life sciences-oriented degree
• Administratively proficient - An excellent communicator in both Dutch and English
• Capable of functioning in a complex, regulated environment, where adaptability is essential and multitasking is required
• Interested in dedicating the first 1.5 to 2 years in this role before transitioning into a monitor position

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.

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