Clinical Research Associate (CRA)

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 organization's.

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.

We are currently looking to  hire experienced CRA II or Senior CRAs to work within our FSP deivision at ICON. This is a client dedicated role where you will work exclusively on one sponsor's trials and SOPs on a range of key therapy areas such as:Oncology, Cardiovascular, Immunology, Neurology and Vaccines.

The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

Responsibilities:

• • • Frontline liaison between the sponsor and sites to ensure successful collaboration, meeting sponsor's expectation on milestone and deliverables with true ownership mindset
    • Manages assigned study sites, conducting phase I-IV protocols according to the monitring plan and sponsor's procedures, 
    • Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects
    • Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
    • Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including
    • Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study tea
    • Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
    • Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at sites
    • Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
    • Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
    • Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date. 

To be successful in the role, you will have:

• Universtity Degree
• Minimum 2 years of independent on-site monitoring experience
• Ability to travel nationally with overnight stays
• Experience conducting all types of MVs such as: Site Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• A demonstrated working knowledge of ICH/GCP Guidelines
• Excellent record-keeping skills and attention to detail
• Fluent in English and local language- both written and oral

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.

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