Clinical Research Associate 2

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.

We are currently recruiting for an experienced Clinical Research Associate in Serbia to work on diabetes, obesity, and rare blood and endocrinology studies. 

This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The Clinical Research Associate (CRA) acts as site manager between site staff and Pharmaceutical Company, working within the local affiliate supporting one or more clinical trial(s) in a development programme. CRA is responsible for tangible trial operational targets (KPIs) and ensuring the highest possible data quality in clinical trial(s).

Key Responsibilities:

Primary point of contact between site staff and the sponsor. Acts as ambassador for the company and contributes to making the sponsor the preferred partner.
Performing monitoring visits according to plan, document actions and follow up on action plans
Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies
Train and guide site staff in the protocol and trial procedures to minimise protocol deviations (PDs)
Train site staff in safety information handling and systems
Know and meet all local and company requirements with respect to safety reporting
Proactive use of data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
Identify potential risks and proactively take action to prevent or mitigate
Collaborate with Data Management/logistics in resolving queries
Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
Ensure collaboration with and deliverables from vendors locally, if applicable
Collection and management of essential documents
Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable

Requirements;

• Bachelor or master degree in Life Sciences or equivalent
• Experience as CRA in the pharmaceutical industry or Clinical Research Organisation (CRO), a minimum of 8-12 months of previous on-site monitoring experience.
• Ability to build and maintain relationships with sites
• High focus on delivery and quality
• Excellent communication and negotiation skills
• High degree of trustworthiness
• Adequate English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports

Why 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.

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.

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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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