Clinical Research Associate (CRA)

Eurofins USA Environment Testing; Hamburg; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading niche CRO in Hamburg seeks a Clinical Research Associate (CRA) to act as a liaison between the sponsor, CRO, and trial site. Key responsibilities include monitoring visits, quality control of clinical trials, and compliance with guidelines. Candidates should have a degree in a scientific or medical field and at least 2 years of clinical monitoring experience, preferably in dermatology. Fluency in German and a high level of English is required.

Qualifikationen

• Min. 2 years of clinical monitoring experience, preferably in Dermatology.
• Very good knowledge of Good Clinical Practice/ICH Guidelines.
• Fluency in German and a high level of English language.

Aufgaben

• Perform all kinds of monitoring visits, including remote monitoring.
• Generate and update monitoring plans and site initiation presentation.
• Evaluate the quality and integrity of site practices.

Kenntnisse

Monitoring visits

Quality control

Communication skills

Interpersonal skills

Organizational skills

Ausbildung

Degree in a scientific or medical discipline

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.

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

• 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!