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Senior Clinical Research Associate (f/m/d)

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Eurofins

11d ago

  • Job
    Full-time
    Senior Level
  • Hamburg
  • Quick Apply

AI generated summary

  • You need a scientific degree, 5 years industry experience, 2 years as CRA, GCP/ICH knowledge, fluency in German/English, and strong communication skills. Dermatology experience preferred.
  • You will coordinate CRAs, provide training, conduct site monitoring for clinical trials, collaborate with stakeholders, input on financial proposals, and implement process improvements.

Requirements

  • Degree in a scientific or medical discipline
  • 5 years of industry experience working on clinical trials/investigations and at least 2 years of experience as CRA in leading position are imperative, ideally including multicenter and multinational trials
  • Open to travel, including overnight stays
  • Advanced knowledge of, and ability to, apply GCP/ICH, ISO 14155 and all applicable regulatory guidelines
  • Fluent in German and English (written and spoken)
  • Well-structured and organized, target-oriented personality, must work both independently and in a team environment
  • Capability to communicate complex issues clearly
  • Candidates with experiences in the indication dermatology will be preferred
  • Home office based work is possible (at least partially office-based work in Hamburg preferred)

Responsibilities

  • Coordinate team of CRAs
  • Co-Monitoring, training and support of junior or freelance CRA team (in-house and freelance CRAs)
  • Act as a CRA and Lead CRA for defined project(s), i.e. performing on-site monitoring (including site selection, initiation, periodic and close out visits) as well as remote monitoring and risk-based monitoring for clinical trials phase I-III
  • Close cooperation with internal interface departments and external stakeholders
  • Giving input to financial proposals for monitoring activities
  • Represents bioskin in bid defenses and investigator meetings
  • Identify and implement possible improvements to current processes, determine new processes that are needed

FAQs

What is the main responsibility of the Senior Clinical Research Associate (CRA)?

The main responsibility of the Senior CRA is to manage all aspects of clinical monitoring to ensure quality, compliance, and oversight to applicable regulations.

What qualifications are required for this position?

Candidates should have a degree in a scientific or medical discipline, at least 5 years of industry experience working on clinical trials, and at least 2 years of experience as a leading CRA.

Is experience in dermatology preferred for this role?

Yes, candidates with experience in the indication dermatology will be preferred.

What languages must candidates be fluent in?

Candidates must be fluent in both German and English, written and spoken.

Is travel required for this position?

Yes, the position requires being open to travel, including overnight stays.

Will I be involved in training junior CRAs?

Yes, the Senior CRA will be responsible for the co-monitoring, training, and support of junior or freelance CRA teams.

What types of clinical trials will I be monitoring?

The Senior CRA will perform monitoring for clinical trials in phases I-III.

Can I work from home?

Yes, home office-based work is possible, although at least partial office-based work in Hamburg is preferred.

How should I submit my application?

You should send your complete application, including your anticipated salary, as a PDF file via email to the address provided in the job description.

Are applications from headhunters or recruiting agencies accepted?

No, contacts by headhunters, recruiting, or staffing agencies are not accepted.

Testing for Life

Technology
Industry
10,001+
Employees
1987
Founded Year

Mission & Purpose

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is a global leader in food, environmental, pharmaceutical and cosmetic product testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In over just 35 years, Eurofins has grown from one laboratory in Nantes, France to over 61,000 staff across a network of independent companies in 61 countries, operating ca. 900 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies. In 2022, Eurofins recorded revenues of €6,712 million.