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Clinical Research Associate (CRA)
Résumé du poste
A leading niche CRO in Hamburg seeks an experienced Clinical Research Associate to manage monitoring visits and maintain compliance with clinical trial protocols. The ideal candidate should have at least 2 years of experience, preferably in dermatology, a degree in a scientific or medical discipline, and excellent communication skills. Proficiency in both German and English is required.
Qualifications
- Minimum 2 years of clinical monitoring experience, preferably in dermatology.
- Very good knowledge of Good Clinical Practice/ICH Guidelines.
- Proven ability to work independently in a fast-paced environment.
Responsabilités
- Perform monitoring visits (site selection, initiation, periodic, and close-out).
- Generate and update monitoring plans and site initiation presentation.
- Evaluate the quality and integrity of site practices.
Connaissances
Formation
Eurofins bioskin is a leading niche CRO with unique understanding and capabilities for both early and late phase development of dermatological and related products. Since its inception in 1992, eurofins bioskin has been recognized as a valuable partner for dermatological product development. Starting as a small Contract Research Organization (CRO) specialized in conducting early phase safety and efficacy trials, eurofins bioskin has grown into a full-service CRO offering global dermatologic consulting and regulatory services and all services for management of Phase I-IV drug trials and claim support/safety studies. eurofins bioskin is headquartered in Hamburg, Germany.
The main task of the CRA is to act as a link between sponsor, CRO and trial site as well as to perform quality control of clinical trials. The focus is on clinical studies conducted in-house at bioskin or in the Northern German region.
- Perform all kind of the monitoring visits (site selection, initiation, periodic and close-out visits) as well as remote monitoring
- Generation and updating of monitoring plans and site initiation presentation
- Evaluating the quality and integrity of site practices
- Act as contact for clinical trial suppliers and other vendors as assigned
- Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
- Close cooperation with the different departments in-house at bioskin as well as freelance CRAs
- Compliance with protocol, GCP/ICH Guidelines
The ideal Candidate will need the following experience to be considered:
- Min. 2 years of the clinical monitoring experience (preferred Dermatology)
- Degree in a scientific or medical discipline or equivalent
- Very good knowledge of Good Clinical Practice/ICH Guidelines
- Proven ability to work independently in a fast-paced environment
- Excellent communication, interpersonal, and organizational skills
- Fluency in German and a high level of English language
- located in Hamburg
Contacts by headhunters, recruiting or staffing agencies are not accepted!
* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.
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