Clinical Trial Associate (Oncology) - Canada

Job Description

Clinical Trial Associate- Remote

Candidates must have experience managing sites in pharma/CRO setting

Oncology experience required

Experience with US sites preferred

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

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

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

What You Will Be Doing:

Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements

• Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders
• Participate in the development of core trial documents and trial level plans, as requested
• Participate in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data
• Participate in feasibility assessment and selection of countries and sites for trial conduct
• Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team
• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
• Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team
• Ensure quality and completeness of TMF for assigned clinical trials
• Participate in trial team meetings and manage associated documentation as requested
• Participate in data cleaning and data review activities as requested
• Participate in or lead set-up and implementation of effective investigator and site monitor training
• Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable
• Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out

Your Profile:

• BA/BS degree with at least two years clinical trial experience
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
• Requires project management skills and trial leadership ability
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
• Fluent in English
• Moderate (10%) travel required