Clinical Research Associate (CRA)

Eurofins USA; Hamburg; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A prominent Contract Research Organization in Hamburg is seeking a Clinical Monitoring professional with at least 2 years of experience, particularly in Dermatology. The candidate must have a degree in a scientific or medical discipline and be fluent in both German and English. This role involves performing monitoring visits, generating reports, and ensuring compliance with clinical guidelines. Excellent communication and organizational skills are essential.

Qualifikationen

• Minimum 2 years of clinical monitoring experience, preferred in Dermatology.
• Ability to work independently in a fast-paced environment.
• Located in Hamburg.

Aufgaben

• Perform monitoring visits and remote monitoring.
• Generate and update monitoring plans and site initiation presentations.
• Evaluate quality and integrity of site practices.
• Act as contact for clinical trial suppliers.
• Identify and escalate protocol deviations and discrepancies.
• Ensure compliance with protocol and GCP/ICH guidelines.

Kenntnisse

Monitoring experience

Knowledge of GCP/ICH Guidelines

Communication skills

Interpersonal skills

Organizational skills

Fluency in German

Fluency in English

Ausbildung

Degree in a scientific or medical discipline

Jobbeschreibung

Company 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

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!