CRA II - NY / PA

Overview

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

Responsibilities

What you will be doing:

• The Clinical Research Associate 2 will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

   

   Responsibilities:

  • Applies knowledge of ICON’s policies and procedures
  • Demonstrates excellent written and oral communication
  • Demonstrates excellent knowledge of ICH/GCP
  • Displays ability to manage investigative sites to facilitate trial deliverables
  • Demonstrates ability to escalate issues appropriately
  • Conducts monitoring to confirm subject safety and data integrity
  • Describes and demonstrates the principals of IP accountability
  • Identifies scientific misconduct at the site level
  • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
  • Mentors CRAs new to the position or company
  • Serves as an observation visit leader
  • Conducts monitoring evaluation visits
  • Assists team lead in the development of trial tools or documents
  • Assists with CTM tasks
  • Participates in the development of process changes/improvements
  • Presents at client meetings/Investigator meetings
  • Provides training to trial teams

Qualifications

You are:

• • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
  • Read, write and speak fluent English; fluent in host country language required.
  • 2 years of experience supporting clinical trials including 1 year of on-site monitoring experience (for CRA2);  4 years of experience supporting clinical trials including 3 years of on-site monitoring experience (for CRA3)
  • Ability to travel for approximately 10 site visits each month
  • Proven success monitoring fast paced trials with quick turnaround times for database lock
  • High proficiency with Microsoft Office and company collaboration applications
  • Advanced skill in utilization of applicable clinical systems
  • Experience in monitoring all trial components (PSSV to COV) is preferred

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, 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 organisation. 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 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.