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Job Details

Senior/Lead CRA (m/f), Frankfurt a.M.

Company: Constares GmbH
Location: Frankfurt a.M.
Reference: LCRA2017
Closing Date: 16 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Our client is a mid-sized global CRO dedicated to serve its clients as a strong partner in clinical development. With approximately 500 employees, the company covers a total of more than 20 countries around the world. For further dynamic growth of our client’s European HQ in Frankfurt a.M., we are currently hiring a Senior/Lead CRA (f/m) office based in Frankfurt a.M.

Requirements:

Our client is a mid-sized global CRO dedicated to serve its clients as a strong partner in clinical development. With approximately 500 employees, the company covers a total of more than 20 countries around the world. For further dynamic growth of our client’s European HQ in Frankfurt a.M., we are currently hiring a

Senior/Lead CRA (f/m)

office based in Frankfurt a.M.

In this challenging position you will be responsible for clinical monitoring activities and managing clinical study sites, ensuring quality service and appropriate clinical study conduct.
 

Responsibilities:

  • Ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs, and any applicable regulatory requirements in the assigned countries
  • Potential to lead a group of CRA, existing experience in line management is beneficial but not mandatory
  • Review of and/or input to the study protocol, CRF and validation tools
  • Preparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documents
  • Preparation of submissions to Independent Ethics Committees (central and local) and to Competent Authorities
  • Assisting with Investigator and Institution contracts, negotiating budgets and arranging site payments
  • Query management in cooperation with the Clinical Data Management Team
  • Assisting sites and the study team in managing contacts to external service providers
  • such as central laboratories
  • Participation in feasibility studies and Investigator selection
  • Responsibility for Site Management
  • Travel as necessary, consistent with project needs within Germany and occasionally outside Germany


Requirements:

  • University degree in sciences or related fields; nursing degree or comparable education
  • Work experience preferably in international projects
  • Experience in an international CRO is beneficial
  • Experience and solid know how in submissions of clinical studies to CA and ECs in Germany, and preferably in other countries
  • Extensive know how and understanding of GCP and the environment of clinical studies
  • Know-how and experience about conduct of medical device studies in Germany is advantageous
  • Self-starting and ambitious attitude to actively drive things forward
  • Fluency in German and English both spoken and written (additional languages are a plus)
  • Friendly, open, motivated and optimistic personality
  • Awareness and willingness regarding remote teams
  • Solid IT - know how about standard PC applications (MS – office)


Our client offers a competitive salary and benefits package reflecting your level of experience. You will be part of a result driven, highly devoted team of clinical research professionals dedicated to improving health and quality of life.


Interested?

Please submit your application to alina.kryzhanovskaya@constares.de and we will reach out to you to further explore this opportunity.

Apply for this job: Senior/Lead CRA (m/f), Frankfurt a.M.

Contact Information:

Address:  Head Office
Elsenheimerstr. 63
Munich
80687
Germany
Tel:  +4989125039835
Website:  Visit Our Web Site

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