Ref #: 32847

Employment type: Permanent - Full-Time

Location: Austria

Posted: 06-Oct-2021

Description

ICON is partnering with one of the most successful global pharmaceutical companies to support them in developing new drugs in critical areas to increase health and quality of live all over the world.
To accomplish this we are currently looking for an experienced Clinical Research Associate (m/f/d).

Location: Germany home base


Key Responsibilities

• Primary point of contact between site staff and our client.
• Responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, client procedures and protocol requirements to ensure data quality and study subject protection.
• Responsible for managing the site to meet patient recruitment rate and target.
• Delivers results that have direct impact on the successful completion of the clinical programme.
• Coordinates with LTM and RTM and communicates to them progress and critical issues that may impair trial progress.


Main Job Tasks

• 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 strategies
• Train and guide site staff in the protocol and trial procedures to minimise 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 our client 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


To Be Successful in The Role You Will Have

• B.Sc. 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 Organisation (CRO). Other experience may also be relevant, e.g. as study staff at a clinical research site.
• Business level of German and English language skills; IT proficiency


What is Offered

• Work for one of the global top two CROs, sponsor dedicated in one of the global top pharmaceutical companies fully integrated and from the sponsor’s perspective
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical sponsors
• Permanent contract
• Great work atmosphere
• Excellent career options
• Contribution to pension scheme


Sounds like a good fit? Get in touch with me today!
Send email to Ruth.Guibourg@docsglobal.com or call at +49 89 666 105 160



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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