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.We are looking for an experienced Clinical Research Associate (CRA) /Lead CRA for our CRA team at Eurofins bioskin in Hamburg. The senior CRA will manage all aspects of clinical monitoring to ensure quality, compliance and oversight to applicable regulations.

 

Focus of tasks:

Coordinate team of CRAsCo-Monitoring, training and support of junior or freelance CRA team (in-house and freelance CRAs)Act as a CRA and Lead CRA for defined project(s) , i.e. performing on-site monitoring (including site selection, initiation, periodic and close out visits) as well as remote monitoring and risk-based monitoring for clinical trials phase I-IIIClose cooperation with internal interface departments and external stakeholdersGiving input to financial proposals for monitoring activitiesRepresents bioskin in bid defenses and investigator meetingsIdentify and implement possible improvements to current processes, determine new processes that are needed

Job Description

We are looking for an experienced Clinical Research Associate (CRA) /Lead CRA for our CRA team at Eurofins bioskin in Hamburg. The senior CRA will manage all aspects of clinical monitoring to ensure quality, compliance and oversight to applicable regulations.

Focus of tasks:

Coordinate team of CRAsCo-Monitoring, training and support of junior or freelance CRA team (in-house and freelance CRAs)Act as a CRA and Lead CRA for defined project(s) , i.e. performing on-site monitoring (including site selection, initiation, periodic and close out visits) as well as remote monitoring and risk-based monitoring for clinical trials phase I-IIIClose cooperation with internal interface departments and external stakeholdersGiving input to financial proposals for monitoring activitiesRepresents bioskin in bid defenses and investigator meetingsIdentify and implement possible improvements to current processes, determine new processes that are needed

Qualifications

Profile:

Degree in a scientific or medical discipline5 years of industry experience working on clinical trials/investigations and at least 2 years of experience as CRA in leading position are imperative, ideally including multicenter and multinational trialsOpen to travel, including overnight staysAdvanced knowledge of, and ability to, apply GCP/ICH, ISO 14155 and all applicable regulatory guidelinesFluent in German and English (written and spoken)Well-structured and organized, target-oriented personality, must work both independently and in a team environmentCapability to communicate complex issues clearlyCandidates with experiences in the indication dermatology will be preferredHome office based work is possible (at least partially office-based work in Hamburg preferred)

Additional Information

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

Please send your complete application including your anticipated salary to:

Bitte senden Sie Ihre vollständige E-Mail-Bewerbung als PDF-Datei mit Gehaltsvorstellung an:

bioskin GmbH • Messberg 4 • 20095 Hamburg Bettina Möhlenbrock •                                      Email: [email protected]

Please send applications by e-mail as pdf file.