CRA II

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.

Clinical Research Associate

ICON Strategic Solutions Alphen aan Den Rijn, South Holland, Netherlands (Hybrid)

 If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. ICON plc is hiring a CRA fully outsourced to our sponsor.

What will be your responsibilities?

• Performing monitoring visits according to plan, document actions and follow up on action plans Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for 
• patient recruitment strategiesTrain and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs)
• Train site staff in safety information handling and systems
• Know and meet all local and company requirements with respect to safety reporting
• Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
• Identify potential risks and proactively take action to prevent or mitigate
• Collaborate with Data Management/logistics in resolving queries
• Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
• Manage trial product requirements, incl. temperature deviations and training of site staff
• Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner
• Ensure collaboration with and deliverables from vendors locally, if applicable
• Collection and management of essential documents
• Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
• Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
• Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (STMF)
• Timeliness in deliverables through process planning and goal setting
• Knowledge of IW/VRS functions, incl. training of site staff
• Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments
• Monitor and communicate internally any site observations critical to business results
• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
• Support audits and inspections at sites and affiliate, as applicable
• Proficient use of Novo Nordisk systems (e.g. IMPACT, CATS, Investigator Portals)
• Ensure to list compliance/quality related tasks/responsibilities and specific, assigned acts of authority (QMS requirements) – also include information on independence and decision-making authority

Qualifications:

BSc. or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region.

• Ideally experience from a similar position in the pharmaceutical industry or Clinical Research Organization (CRO).
• Other experience may also be relevant, e.g. as study staff at a clinical research site.
• Ability to build and maintain relationships with sites.
• Responsible and accountable.
• Excellent communication and negotiation skills.
• High focus on delivery and quality.
• Adequate Dutch and English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports.
• IT proficiency.
• Proven decision making and problem-solving capabilities.
• Ability to manage multiple priorities.
• Team oriented personality with high degree of flexibility.
• Ability and willingness to adjust quickly to new situations in a continuously developing environment.
• High degree of trustworthiness.
• Act as an ambassador.
• Flexibility
• Fluently Dutch and English 

• What’s in it for you?
• As a CRA, you have the opportunity to grow and to learn.
• It is a Hybrid based position (Alphen ad Rijn) with the flexibility to work from home
• A very good work/life balance
• Limited visits 4/5 per month.
• We offer you a fixed contract of one year, meaning to make it a permanent contract at ICON with an extensive package of extra-legal benefits.

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.