TMF Clinical Trial Associate - Remote, US

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

Job Duties will Include:

• Ensures a complete, accurate and high quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partner relationship with the study team
• Provides feedback, support and training to study teams in order to build knowledge and awareness of good, quality documentation management practices for clinical trials.
• Clinical study team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical trials.
• Responsible for tracking study budgets, including invoice and PO
• management/reconciliation, and accruals in support of the CTM and Finance.
• Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects.
• Responsible for set-up, filing, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files.
• Responsible for data entry into Clinical Trial Management Systems.
• Supports and/or tracks external access rights to Clinical Trial Management Systems.
• Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues.
• Manage and track clinical and non-clinical supplies.
• Assists CTM with agendas and meeting minutes for clinical sub-team meetings.
• Assists CTM with logistics coordination for investigator meetings and external vendor meetings.
• Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs) and contracts with Sr. Manager Clinical Operations, legal, and finance departments.
• Responsible for facilitating site advertisement review and approval with CCC Committee.
• Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act etc.

Qualifications:

• Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred 
• Experience: 1-2 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
• Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
• Strong interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem solving skills
• Self-motivated and displays initiative
• Perform job duties with minimal supervision and guidance
• Ability to work effectively work in a team setting

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.