Senior CRA

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 Senior Clinical Research Associate in Romania to work for a global biotechnology company.

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 CRA is responsible for the preparation, 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.

• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
• Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
• Provides regular site status information to team members, trial management, and updates trial management tools.
• Completes monitoring activity documents as required by SOPs or other contractual obligations.
• Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
• Performs essential document site file reconciliation.
• Performs source document verification and query resolution.
• Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
• Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
• Communicates with investigative sites.
• Facilitates audits and audit resolution.
• To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.
• If responsible for supervising other CRAs, schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with vendor’s policies, procedures, and SOPs, and ensures HR processes are properly implemented.
• May support new CRA training
• Functions independently with minimal oversight required.
• May serve as subject matter expert for clinical operations on monitoring-related activities.
• May be assigned to complex studies and/or sites.
• Provides leadership skills to assigned projects and within the Clinical Operations department.

Requirements:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required.
• 4 or more years of clinical monitoring experience required.
• Previous experience in monitoring oncology studies would be an advantage
• Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV]) preferred.
• Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
• Experience in coaching/mentoring other CRAs preferred.

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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