Clinical Research Associate - Oncology #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.
As a CRA, you will;

• Serve as a primary contact point between the sponsor and the investigational site.
• Be assigned to trial sites ensuring inspection readiness through compliance with the Clinical Research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through to data-base lock.

Responsibilities include;

• Site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
• Partnering with the CTA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols.
• May contribute to process improvement and training
• Contribute to the selection of potential investigators.
• Provide the required monitoring visit reports within required timelines
• Drive performance at the sites. Proactively identify study-related issues and escalate as appropriate.
• Perform source data verification according to SDV plan and ensure data query resolution
• Initiate, monitor and close study sites in compliance with client Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.
• Train, support and advise Investigators and site staff in study related matters.

Experience required:

• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• A minimum of 2 years of independent clinical trial monitoring experience is required
• Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Good IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills