Clinical Trial Associate - Remote

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.

Performs the role of Clinical Trial Assistant (CTA) supporting the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.

Performs regulatory document review and approval, including site specific Informed Consents.

Ensures trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTA’s.

• Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
• Supports the local study team in performing site feasibility and/or country feasibility.
• Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
• In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
• Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
• Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
• Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post trial in both eTMF (i.e., IF/LAF sections) and paper files.
• Distributes, collect, review, and track regulatory documents, agreements and training documentatio
• Collects and tracks Financial Disclosure information at appropriate time points.
• May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
• May be assigned as a coach and mentor to a less experienced CTA.
• Complies with relevant training requirements.

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.