Study Start Up Associate II

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.

Study Start Up Associate II

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials.

The Role:

• Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.

• This may include: Prepare, review and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF),

• Prepare, review and negotiate Clinical Trial Agreements, budgets and any required ancillary agreements with assigned Study Sites, including the facilitation of the indemnification process, between Sponsor and Study Site,

• Collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries,

• Essential Country and Site document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.

• Embrace and contribute to ICON's culture of delivery, quality and process improvement with a focus on internal stakeholders' collaboration, enhancing processes, systems and tools, adding value to our business, shortening Site Activation timelines and meeting client's expectations. This will translate in predicting and delivering site activation within predicted timelines, and ahead of industry standards

What you need:

• A bachelor's degree or related business experience is preferred

• 2 years + of SSU experience including experience in SAHPRA (CA) and EC initial submission.

• Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.

• Excellent written and verbal communication in English

• Ability to work to tight deadlines

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, 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 through the form below.