Clinical Trial Associate

Pharmaceutical Research Associates, Inc; Canada; Remote; CAD 55,000 - 75,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Trial Associate to manage the day-to-day operations of clinical trials. This role involves ensuring compliance with regulatory guidelines and maintaining trial documentation. Applicants should have a BA/BS degree and at least two years of experience in clinical trials, along with strong project management and communication skills.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• At least two years of clinical trial experience.
• Strong understanding of clinical drug development processes.
• Fluent in English; moderate travel required.

Responsibilities

• Support day-to-day operations of clinical trials.
• Maintain accurate trial information in tracking systems.
• Participate in trial document development and management.

Skills

Project Management

Interpersonal Skills

Communication

Knowledge of ICH/GCP Guidelines

Education

BA/BS Degree

Job description

Overview

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

Responsibilities

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

Qualifications

Qualifications:

• 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

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/benefitsAt 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, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.