Clinical Research Associate - Northeast - Early Development

Overview

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 Research Associate II assigned to Early Development trials (Phase I).

Responsibilities

What you will be doing :

• Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
• Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
• Proactive site management including :
• Building and maintaining solid and professional relationships with site staff
• Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
• Maintaining site audit / inspection readiness
• Ensuring appropriate safety reporting and use of on-line safety reporting / reviewing systems
• Verification of electronic case report form data against written and electronic source documentation as per study schema / monitoring plan
• Responding to site queries and escalating issues in accordance with processes and timelines
• Conducting IP accountability and reconciliation
• Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
• Maintenance of site study supplies

Qualifications

You are :

• BA / BS / BSc in the sciences or nursing equivalent
• A trained CRA with at least 2 years of on-site monitoring experience in phase I trials
• Working knowledge of Electronic Data Capture (preferred)
• Experience / working knowledge of the oncology disease area (preferred)
• Experience of Centralized / Risk Based / Targeted monitoring (preferred)
• Experience of working within a metric based environment (preferred)
• Comprehensive knowledge and understanding of ICH-GCP
• Fluent oral (face to face and telephone) and written English / French language skills
• Able and willing to travel up to 60% of the time to sites in the Northeast USA
• Possession of a full driver’s license
• Able and willing to work from a designated and appropriate home office as per local requirements
• Willing to attend and contribute to team meetings including mandatory training (remote / off-site)
• Competent computer skills including working knowledge of common software packages
• Working knowledge of trial management databases and on-line systems
• Able to attend a 1 week face to face in-house training course as part of on-boarding training
• Able and willing to work on several protocols / therapy areas

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 :

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.

We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. 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, color, 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 .

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