Senior CRA

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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.

What you will be doing:

• Identify, select, initiate and closeout appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP.
• Provide a benchmark of monitoring competence to inexperienced/less-experienced colleagues.
Recognize, exemplify and adhere to ICONs values which centre on our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Ability and willingness to travel at least 60% of the time (international and domestic : fly and drive)
• Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.
• Familiarity with ICON systems
• Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Recruitment of investigators.
• Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:
• Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
• Keep the Project Manager regularly informed.
• Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.
• Ensure the satisfactory closeout of investigator sites.
• Maintain patient and sponsor confidentiality.
• Other duties as assigned.

You will need:

• 3 years+ 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

Benefits of Working in ICON:

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.

At 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.

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, 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.