Clinical Research Associate

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are currently recruiting for an experienced Clinical Research Associate ( CRA II & SeniorCRAs) in Romania. This particular CRA role is a client dedicated one where you will be monitoring studies in such therapeutic areas as immunology, pulmonology, oncology, cardiovascular or neroscience.

• The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.). 
• Drive study compliance by executing activities within site initiation and start‐up, site monitoring, site management and site/study close‐out according to internal SOPs and policies.
• Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.  
• Contribute to site level recruitment strategy and contingency planning and implementation in  partnership with other functional areas to achieve clinical research target. 
• Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines. 
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents. 
• Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations
• Collaborates with Local Study Manager for documenting and communicating site/study progress and issues to trial central team. 
• Works closely with Local Study Manager to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit 

Requirements:

• Bachelor or master degree in Life Sciences or equivalent
• Minimum of 7-18 months of previous experience in independent on-site monitoring of clinical trials
• Ability to build and maintain relationships with sites
• High focus on delivery and quality
• Excellent communication and negotiation skills
• 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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