Senior Clinical Research Associate

vor 1 Tag

Berlin, Berlin, Deutschland Oxford Global Resources Vollzeit
Job Title: Senior Clinical Research Associate

We are seeking an experienced Senior Clinical Research Associate to join our team at Oxford Global Resources. As a Senior CRA, you will play a key role in the execution of clinical studies to assess the safety and effectiveness of Medical Devices products.

Responsibilities:
  • Participate in clinical research site management, qualification, initiation, routine monitoring, and final close out.
  • Assist with the development and edits of Informed Consent.
  • Manage device accountability, inventory, and distribution.
  • Monitor ongoing compliance with study protocols and global regulatory guidelines, including safety reporting.
  • Prepare and deliver presentations of protocols and other study requirements at site initiations.
  • Manage distribution, collection, and tracking of regulatory documentation.
  • Conduct site visits, as necessary, and work with clinical sites to resolve any site-related issues quickly and effectively.
  • Assist Clinical management with regulatory submissions and other reports as required.
  • Assist with the development and/or maintenance of Clinical infrastructure, such as drafting or reviewing SOPs and Work Instructions.
Requirements:
  • Bachelor or Master degree.
  • Business English and native German and/or French.
  • Five (5) years' experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required, and min 3 years of clinical monitoring experience required.
  • Medical Devices experience required.
  • EC Submission experience required.
  • Excellent verbal, written, and interpersonal communication skills.
  • Strong organizational and problem-solving skills.
  • Keen attention to detail.
  • High level of competence in Word, Excel, PowerPoint or equivalent programs.
  • Ability to work in teams and with multiple projects.
  • Ability to provide guidance and mentoring to junior Clinical staff.
  • Existing right to work in Europe required.
Information:
  • Long term project.
  • Payroll/Freelance.
  • 0.8 to 1.0 FTE.
  • Remote position with ad-hoc travel for on-site SQV.

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