Clinical Research Associate Ii/ Cra Ii

Vor 2 Tagen

Wien, Österreich Thermo Fisher Scientific Vollzeit

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our global Clinical Monitoring department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programmes, minimise delays and execute high-quality, cost-efficient clinical studies.

Currently we are looking for a Clinical Research Associate II (CRA II) in Austria. The position is home based and will require travelling in the country.

In this role you will:

- Perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.
- Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
- Manage procedures and guidelines from different sponsors and/or monitoring environments.
- Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and
- Ensure audit readiness.
- Develop collaborative relationships with investigational sites.
- Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.

Education and Experience required:

- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation
- Demonstrated understanding of ICH-GCP, EU and FDA requirements
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Exceptional communication, collaboration, organisational and time management skill
- Fluent German and English

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD, part of Thermo Fisher Scientific truly values a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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