Clinical Research Associate (CRA)

Eurofins USA Clinical Diagnostics; Hamburg; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading clinical research organization in Hamburg is seeking a Clinical Research Associate (CRA) to oversee clinical studies and ensure compliance with regulations. The role requires a minimum of 2 years of clinical monitoring experience, preferably in Dermatology, along with excellent communication skills. Fluency in German and a strong command of English are essential. This is a full-time position focused on supporting trials in-house and in the Northern German region.

Qualifikationen

• Minimum 2 years of clinical monitoring experience, preferably in Dermatology.
• Proven ability to work independently in a fast-paced environment.

Aufgaben

• Perform various monitoring visits and remote monitoring.
• Evaluate the quality and integrity of site practices.
• Identify and escalate protocol deviations.

Kenntnisse

Clinical monitoring experience

Knowledge of Good Clinical Practice/ICH Guidelines

Excellent communication skills

Fluency in German

High level of English

Ausbildung

Degree in a scientific or medical discipline

Jobbeschreibung

Overview

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.

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 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

Additional Information

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