Ref #: 29687

Employment type: Permanent - Full-Time

Location: Ukraine

Posted: 23-Jul-2021

Description

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.



Summary of the role:

This CRA role is a client dedicated position where you will work exclusively on one sponsors trials and SOPs. Previous experience in on-site monitoring ( a minimum of 1.5 years as in a CRA role) is required.

CRA serves as primary contact point between the sponsor and the investigational site. Responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.



Requirements

life science or medical related university degree ( biology, pharmacy, biotechnology, medicine, etc)
a minimum of 1.5 years' of experience in independent on-site monitoring of clinical trials
willingness to travel with occasional overnight stay away from home.
fluent English.
be able to work office-based in Kiev

Key Responsibilities:

Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
You will be involved in preparation of regulatory submissions, adaptation and translation of local ICFs, etc.
You will act as primary local company contact for assigned sites for specific trials.
As a CRA you will be responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
You will ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
You will ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
You will ensure that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate.
You will maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoint )
You will fully document trial related activities in particular monitoring - write visit reports and uploads into eTMF , etc
You will prepare trial sites for close out, conduct final close out visit


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.
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