Clinical Research Associate

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.

ICON Strategic Solutions are currently recruiting for a CRA II or Senior CRA in Bulgaria to work on a range of therapeutic areas including Cardiovascular, Immunology, Neuroscience, Solid Tumors and Hematology. 

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.

Responsibilities: 

• Managing assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and sponsor's procedures;
• Being the frontline liaison between the sponsor and sites to ensure successful collaboration, meeting sponsors expectation on milestone and deliveries;
• Performing remote and on-site monitoring activities to ensure compliance with protocol, ICH-GCP, global and local regulations, global and local processes to secure data integrity and patient safety;
• Conducting continuous monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned; (i.e., study start-up, recruitment, database analyses, closeout, etc.)
• Conducting site visits including but not limited to selection visits, initiation visits, monitoring visits, close-out visits per SOPs and applicable regulations and documenting monitoring activities appropriately following sponsor's standards;
• Identifying issues at sites; resolving issues and escalating as appropriate;
• Managing and maintaining information and documentation by updating all electronic systems (global and local) relevant to perform job functions;
• Participating from audit organization and inspection readiness activities for monitoring and site related activities as required and ensuring implementation of corrective actions within specified timelines

Requirements:

• BA/BS , preferably in the Life Sciences, or RN
• Previous monitoring experience (minimum 12 months) is essential gained in pharma/CRO.
• Ability to travel domestically (a minimum of 50% overnight travel may be required).
• Ability to anticipate potential issues and take appropriate actions with or without supervision.
• Good knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVRS and CTMS systems

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.