Clinical Research Associate (CRA)

Eurofins USA Agroscience Services; Hamburg; Vor Ort; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

A leading niche CRO in Hamburg is seeking a Clinical Research Associate to ensure quality control of clinical trials. The role involves monitoring visits, evaluation of site practices, and compliance with regulatory guidelines. The ideal candidate will have at least 2 years of experience, a degree in a relevant field, and fluency in both German and English. This role offers the opportunity to work in a fast-paced environment with strong communication and organizational skills required.

Qualifikationen

• Min. 2 years of clinical monitoring experience (preferred Dermatology)
• Very good knowledge of Good Clinical Practice/ICH Guidelines
• Proven ability to work independently in a fast-paced environment

Aufgaben

• Perform monitoring visits for site selection, initiation, periodic and close-out visits
• Generate and update monitoring plans and site initiation presentations
• Evaluate quality and integrity of site practices
• Act as contact for clinical trial suppliers and other vendors

Kenntnisse

Clinical monitoring experience

Communication skills

Understanding of Good Clinical Practice

Ability to work independently

Excellent organizational skills

Interpersonal skills

Fluency in German

Fluency in English

Ausbildung

Degree in a scientific or medical discipline or equivalent

Jobbeschreibung

Company Description

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.

Role Overview

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.

Responsibilities

• 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

Qualifications

The ideal Candidate will need the following experience to be considered:

• Min. 2 years of theclinical 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

Additional Information

Contacts by headhunters, recruiting or staffing agencies are not accepted!