Trial Master File (TMF) Clinical Trial Coordinator - Home-Based

As a TMF Clinical Trial Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role maintains Trial Master Files for assigned studies under moderate supervision, participating in end-to-end TMF activities, including: adherence to organizational TMF standards and study-level quality control reviews and facilitating issue resolution.

Responsibilities: 

• Ensure TMF completeness and accuracy based on client SOPs and regulatory requirements.
• Maintain study-level TMFs including planning and setup, QC reviews, basic analysis, and vendor  oversight
• Conduct content review of a variety of documents in a short time frame while maintaining  consistency and attention to detail
• Prioritize work accordingly to meet departmental needs and work toward and meet deadlines with  moderate supervision
• Generate metrics for department and study team usage supporting TMF completeness, accuracy  and quality
• Participate in inspection readiness reviews and preparation activity
• Provide training as applicable to TMF stakeholders
• Participate in the onboarding of new staff
• Participate in straightforward projects that may require cross-functional collaboration or involve coordinating system updates 

• Bachelor's degree preferred
• 2 years of relevant work experience in a clinical development setting, or an equivalent combination of education and experience
• Experience with MS Excel, MS Project, MS PowerPoint, MS Word, SharePoint, eTMF
• Detail orientated
• Strong Communication skills
• Possess good critical thinking skills with a focus on inspection readiness

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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.