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Clinical Research Associate 1-3 (m-f), Germany, Pharmaceuticals

Employer
ICON GSS - EMEA
Location
Germany, Homeworking
Salary
Competitive
Start date
2 Nov 2022
Closing date
2 Dec 2022

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

We have a Clinical Research Associate / Senior CRA position available to join our team and to partner with a highly reputed mid-sized pharmaceutical company. The job title for this role is Clinical Research Associate 1, CRA 2 or CRA 3, depending on your experience.

We welcome Junior CRAs or candidates who have completed CRA training to apply for this role. Fluent German and fluent English speaking is essential.

As a CRA 1-3 you would be client dedicated to a pharmaceutical company who are highly established in dermatology.

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.

About ICON:

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

- Detail-orientated, passionate and reliable.

- Any experience as a CRA working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment is preferred.

- 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).

- Be willing to travel frequently

- Fluent German and English.

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.

Would you like to know more? Please contact the lead recruiter, michael.kellitt@docsglobal.com

We are looking forward to your application!

Michael Kellitt

Senior Recruitment Consultant DACH

+49 173 170 2681

michael.kellitt@docsglobal.com

Konrad-Zuse-Platz 11, 81829 München

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
GB
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