Clinical Trial Assistant

ICON plc • Blue Bell, SD

1d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Requirements

• BS/BA degree or degree in healthcare field required
• Entry level experience supporting clinical operations activities, typically 1+ years in sponsor company or 2 years of experience in a CRO environment
• Basic knowledge of drug development and clinical operations processes
• Foundational knowledge of clinical trial process and supports study activities in accordance with ICH-GCP and Code of Federal regulations
• Effective written and verbal communication skills, with the ability to work collaboratively within study teams
• Strong organization and interpersonal skills
• Foundational experience with eTMF systems and basic knowledge of essential documents to file study documents accurately with guidance
• Strong attention to detail
• Able to prioritize and manage multiple tasks with competing deadlines
• High sense of urgency and commitment to excellence in the successful execution of deliverables
• Demonstrates ability to identify issues and escalate appropriately to support timeline adherence
• Proficient with MS Office Suite (Excel, Word, PowerPoint) and project tracking tools

Responsibilities

• Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
• Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
• Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
• Set up, organize and maintain study files and shared spaces in accordance with study requirements
• Coordinate and track study training
• Manage study sample and supply tracking and support interactions with vendors as needed
• Support the Study Management team with specific projects
• Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues
• Perform routine quality checks on trial level documents to ensure completeness and accuracy
• Supports the timely, complete and compliant archiving in the TMF
• Participate in company, departmental and project team meetings including Investigator Meetings
• May assist with basic financial and budget tracking activities related to the clinical trial.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level