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Senior Clinical Research Associate (CRA)

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
    Healthcare
  • Madrid

AI generated summary

  • You need a relevant degree, clinical research experience, monitoring in device studies, strong English skills, communication abilities, team spirit, customer focus, and willingness to travel (20%).
  • You will ensure compliance with regulations, supervise monitoring activities, maintain study documents and budget, communicate with IRBs, handle adverse events, and prepare necessary reports.

Requirements

  • Education in relevant field ((dental) medicine, life sciences, engineering, material sciences, etc.)
  • Relevant work experience in clinical research
  • Relevant experience in monitoring, preferably in device studies
  • Fluent in written and spoken English
  • Excellent communication and interpersonal skills
  • Dynamic and self-motivated person, comfortable working in a matrix environment
  • Distinct customer orientation both internally and externally
  • Team player
  • Willingness to travel (approx. 20%)

Responsibilities

  • Works in compliance and conformity with ISO/GCP Guidelines, the Declaration of Helsinki, SOPs and applicable legal and regulatory requirements
  • Supervises internal and outsourced monitoring activities during all phases of the study
  • Supports Study Management with
  • Maintaining study documents, in particular the electronic TMF
  • Maintaining the Clinical Trial Management System
  • Communication with IRB/EC and RA, if applicable (e.g., annual safety reports, protocol deviations, SAEs, amendments)
  • Handling Adverse Event reporting
  • Administrating contracts and study budget
  • Prepares reports to IRB/EC and RA, if applicable

FAQs

What is the job title for this position?

The job title is Senior Clinical Research Associate (CRA).

Where is the workplace for this position?

The workplace is located at Straumann Group’s Southern European Hub in Madrid, Spain.

What are the main responsibilities of the Senior CRA?

The main responsibilities include ensuring compliance with ISO/GCP Guidelines, supervising monitoring activities, maintaining study documents, handling adverse event reporting, and preparing reports to IRB/EC and RA.

What type of educational background is required for ideal candidates?

Ideal candidates should have an education in a relevant field such as (dental) medicine, life sciences, engineering, or material sciences.

Is relevant work experience required?

Yes, relevant work experience in clinical research is required, with a preference for experience in monitoring device studies.

What language proficiency is expected for applicants?

Applicants must be fluent in written and spoken English.

What qualities are sought in an ideal candidate?

The ideal candidate should have excellent communication and interpersonal skills, be dynamic and self-motivated, possess a distinct customer orientation, be a team player, and be comfortable working in a matrix environment.

Is travel a requirement for this position?

Yes, there is a willingness to travel required, approximately 20%.

Does the company provide equal employment opportunities?

Yes, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

What is the employment type for this position?

The employment type is full-time.

Manufacturing & Electronics
Industry
5001-10,000
Employees

Mission & Purpose

The Straumann Group is a global leader in dental solutions, specialising in implantology, restorative dentistry, and digital technologies. The company develops and manufactures dental implants, instruments, prosthetics, and cutting-edge digital tools to improve patient care and treatment outcomes. Straumann's ultimate mission is to restore confidence and smiles through innovative dental solutions that improve the quality of life. Their purpose is to deliver high-quality, science-based dental products and services that enhance oral health, fostering long-term partnerships with dental professionals and improving patient care worldwide.