CRA II

Overview

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.

Responsibilities

- 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

Requirements

- 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) and should possess a valid driving license

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: careers.iconplc.com/benefits

At 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, 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. careers.iconplc.com/reasonable-accommodations

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.

#J-18808-Ljbffr