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Clinical Research Associate 2

Employer
ICON Strategic Solutions - EMEA
Location
Germany, Homeworking
Salary
Competitive
Start date
1 Jan 2023
Closing date
30 Jan 2023

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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.

• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits for studies of all phases (I, II, III, IV and NIS) in a range of different indications.
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
• Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings
• Build and maintain solid and long-term professional relationships with investigators and site staff

• BA/BS/BSc degree or similar
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA for 2 years
• Proficiency in English and German
• Willingness to travel
• Good working knowledge of common software packages
• Flexibility and Team skills

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.

Company

ICON is the leading provider of Functional Service Provision (FSP) globally. Our team of operational, functional and therapeutic specialists offer a range of FSP models that can be customised to deliver the most efficient operating model for your organisation. We bring a suite of capabilities, expertise and technology to augment your operations, increase R&D efficiencies and improve site engagement to access patient populations and deliver timelines and milestones. We have deployed FSP solutions across all major functions from clinical monitoring and project management through data management, statistical programming and beyond.

 

ICON FSP experience

  • 90+ FSP partnerships
  • 13,000+ Employees
  • 90+ Countries

 

Functional areas

Our offering includes a range of globally scalable FSP solutions that are customised to provide support where and when you need it. We have significant experience in providing bespoke FSP solutions, particularly in:

  • Study start-up
  • Project Management
  • Clinical monitoring
  • Pharmacovigilance / Safety
  • Clinical Supplies Management
  • Data management

Biostatistics and programming

Contracts management

  • Investigator payments
  • Clinical vendor management & category management
  • Medical writing
  • Medical affairs
  • Regulatory affairs
  • Regulatory publishing
Find Us
Website
Location
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
United Kingdom
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