Ref #: 31871

Employment type: Permanent - Full-Time

Location: South Korea

Posted: 01-Sep-2021


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.

The Role: Study Start-up Associate (II-Senior)

Key responsibilities:
- Prepare site specific ICF and any other relevant forms according to sponsor’s local SOP.
- Prepare and compile dossier for initial HA and IRB submission or amendment and oversee associated activities, responses and communications with obtaining approvals for the assigned country(ies).
- Translation of applicable study documents to local language.
- Provide support for trial budget and investigator site payments; support the project manager and team with financial tasks.
- Maintains oversight of the entire purchase order process, from set-up to reconciliation, as well as the processing of study invoices.
- May support, track and/or process grant applications.
- May mentor/on-board newly hired Clinical Trial Assistants and provide on-the-job training, as needed.
- May have some accountability for processes or groups of trials; operates with limited oversight.
- May ensure the successful negotiation and ongoing management of clinical disclosure agreements with investigative sites

Required experience and qualifications:
- More than 2 years of experience as SSU/In-house CRA
- IRB Initial Submission experience is must
- Essential document validation experience preferred
- Budgeting experience preferred
- Essential Document Validation (Localization) experience preferred

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.