CRA I

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we
advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and
government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save
lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON
people have a mission to succeed and a passion that ensures what we do, we do well.

Position overview:
The Clinical Research Associate (CRA) 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.

What you will be doing:

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are
compliant with applicable local regulatory requirements and ICH-GCP guidelines
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs
site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
• Provides regular site status information to team members, trial management, and updates trial management
tools
• Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
• Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
• Performs essential document site file reconciliation
• Performs source document verification and query resolution
• Assesses IP accountability, dispensation, and compliance at the investigative sites
• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
• Communicates with investigative sites
• Updates applicable tracking systems
• Ensures all required training is completed and documented
• Serves as observation visit leader
• Facilitates audit s and audit resolution

• Mentors junior level CRAs and serves as a resource for new employees
• Serves as observation and performance visit leader
• May be assigned additional Clinical Operations tasks
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial
timelines
• May be assigned clinical tasks where advanced negotiating skills are required

You are:

• 12 months+ of monitoring experience in phase I-III trials as a CRA
• College degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication
• Ability to work to tight deadlines
• Availability to travel least 60% of the time (international and domestic -fly and drive)

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

Interested 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.