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Date Added: Sun 06/03/2022

Clinical Research Associate

Germany (DE), Germany
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Company: ICON GSS - EMEA

Job Type: Permanent, FullTime

Clinical Research Associate

LOCATION: GERMANY - HOME BASED

As a Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

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

  • Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
  • Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
  • Proactive use of EDC and other data source systems for preparation and conduct on 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
  • Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
  • Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
  • Collaborate with and provide oversight of deliverables from vendors locally, if applicable
  • Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
  • Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
  • 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
  • We believe our Clinical Operations team is second to none. You will receive the support you need to develop personally and professionally and work in an environment where you matter. Our team pushes forward together. United in solving problems, developing close site relationships and reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients’ drug development processes.

Your are:

- Detail-orientated, passionate and reliable.

To enable success in this position you will have:

  • Prior experience as a CRA working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
  • 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.
  • Knowledge of filing and archiving trial documentation in the Trial Master File (TMF).


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.

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