Clinical Research Associate (CRA)

Eurofins USA PSS Insourcing Solutions; Hamburg; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading CRO is seeking a Clinical Monitor to oversee monitoring visits and ensure compliance with clinical trial protocols in Hamburg. The ideal candidate will have a degree in a relevant 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 are required. This role offers the opportunity to work in a fast-paced environment and collaborate with various departments.

Qualifikationen

• 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.

Aufgaben

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

Kenntnisse

Clinical monitoring experience

Knowledge of GCP/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.

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!