Senior 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.

The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.

What you will be doing:

Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.

• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.

• Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.

• Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.

• Verifies proper management and accountability of Investigational Product (IP).

• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.

• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study;assists with resolution of investigational site/data queries.

• Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.

• Participates in audit preparation and follow-up activities as needed.

Independently performs a wide variety of onsite and offsite monitoring visit types. May be assigned studies that require complex therapeutic knowledge.

You are:

• 2-3 years of experience supporting clinical trials including 2 years of on-site monitoring experience
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
• You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
• Fluent in English and Slovak language required
• We are happy to review in house CRAs and CTAs who want to continue their career as CRA

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.