In Vitro Diagnostics CRA

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Job 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!

In Vitro Diagnostics Clinical Research Associate (m/f/d)

Location: Germany Home Base

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 IVD Clinical Research Associate (m/f/d).

The Clinical Research Associate (CRA) is accountable for designing, planning, coordinating, conducting and overseeing all activities involving in initiation, monitoring, and completing clinical research studies for in vitro diagnostics. The tasks will be discussed and assigned according with study Monitoring Plans, which will be filled out by a client ISM representative.

Key Responsibilities
Supports Site Qualification and Site Initiation per study Monitoring Plan
• Supports the Study start up activities (e.g. Workbooks, Databinder) process and/or using electronic Roche tools, such as eTMF, CTMS
• Supports client instrument set up and internal application testing
• Supports Site Qualifications, Site Initiation Visits and site preparation tasks
• Supports for data management activities e.g. with WinCAEv or Medrio
• Support inventory and logistics of required evaluation/clinical trial material in CTMS and with sites
Supports Site Monitoring per Monitoring Plan
• Supports Monitoring log reviews e.g. Daily Logs, Temperature Logs, Sample Logs
• Performs risk assessments
• Verifies that source data and associated documents as well as other trial records are accurate, complete, and maintained meeting expected compliance standards
• Supports the Data Validation in WinCAEv, performing of SDR in WinCAEv and interim calculation of the results
• Supports SDV onsite (e.g. Informed Consent Forms and/or patient data checks)
• Maintenances eTMF and CTMS systems
• Ensures studies are conducted and documented in accordance with the study protocol, Standard Operating Procedures, Good Clinical Practices and other applicable regulatory requirements, such as FDA regulations, IVD Directives and with Client policies and procedures
• Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives and deliverables are met.
• Interfacing with cross functional staff to support activities.
• Reviewing data with investigators and sites to resolve discrepancies.
• Participation in study team calls and/or meetings to review progress of ongoing clinical trials.
• Participation in Client training calls and study meetings.
Support Close-Out per Monitoring Plan
• Support data review e.g with WinCAEv ensuring readiness for database lock
• Supports final SDR and calculations
• Supports close-out documentation, checks and associated tasks
• Supports preparation of Data for the Study Report
• Archive Study Records / Database according to guidelines and Standard Operating Procedures
• Performs final maintenance of eTMF and CTMS, and archiving if applicable
• Contributes as applicable to audits, inspections and lessons learnt.
Others
• Ability to travel to campuses in Mannheim and Penzberg or Rotkreuz (if needed) for study meetings and role-specific or R&D training, as applicable
• Business travel within Germany and Europe required ~30% , if possible

To Be Successful in The Role You Will Have
• Medical technology degree preferred (Minimum - Bachelor's degree in science or relevant field) "Bachelor of Science Biology" preferred
• MTA (medizinisch technische Assistentin), BTA (Biologisch Technische Assistentin) with analyser experience; Medical Technologists with lab/analyser experience
• Up to 2 years of experience in CRA IVD role, Medical laboratory and customer experience preferred
• Experiences with data analysis is beneficial
• Fluent in spoken and written English and German
• Advantages:
Good Laboratory Practice knowledge/ Experience working with Sponsor-trials/ Experiences with blood gas instruments/ Pre-analytical processes and PCA sample handling/ Knowledge of the requirements for clinical data monitoring/ Experience in diagnostic Laboratory and or analytical analyzer
• Familiar with working to SOPs
• Demonstrated experience in computer skills to include Microsoft Office, and basic templates

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 or call at

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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