Ref #: 29537

Employment type: Permanent - Full-Time

Location: Germany

Posted: 20-Aug-2021

Description

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.


Roles & Responsibilities of the position:

The Clinical Research Associate will be responsible for monitoring local clinical studies in Germany and is the primary contact point between the sponsor and the investigational sites.
A successful candidate is 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 data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.


Key Responsibilities:


• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
• Ensures site staff are trained, site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct and clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff






To be successful in the role, you will have:

• You have already gathered at least 2 or more years of clinical onsite monitoring experience
• Very good communication skills to establish and maintain great work relationships with sites and colleagues
• Proficient in speaking and writing German and English
• Willingness to travel 2-3 days per week on average



What is offered:

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• 100% Home based
• Permanent contract
• Great work atmosphere
• Compensatory time-off
• Contribution to pension scheme
• Company car or car allowance
• Travel time = work time


To apply:
Would you like to know more? We are looking forward to your application by either submitting your CV via email to anja.potrafke@docsglobal.com or apply via our career portal on www.docsglobal.com. We are looking forward to hearing from you.


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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