CRA II/Senior CRA - Germany

€45000 - €46000 per annum
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. Germany
Munich, Germany
Posting date: 05 Apr 2021
36788

A large pharmaceutical company is currently recruiting for a CRA II/Senior CRA position with their Germany office, with national travel. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.

Job Responsibilities

  • Monitoring assigned clinical trials and ensuring investigators are conducting the clinical study within requirements of the clinical protocol and applicable regulations.
  • Serving as the primary contact with the investigators.
  • Coordinating all correspondences with clinical sites.
  • Conducting periodic site file audits to ensure compliance with GCPs and company standard operating procedures.
  • Writing monitoring reports after each monitoring visit on time.
  • Regularly communicating with clinical sites and ensuring documents in Trial Master File are up to date.
  • Participating in the clinical site recruitment process. Performing site initiation and close-out activities.
  • Preparation of study initiation documents.
  • Working with clinical site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
  • Maintaining an effective interface with the company's commercial operations to ensure the interface with clinical study sites is managed professionally and is well-coordinated to build goodwill and business value.
  • Working closely with the Clinical Data Manager to ensure data captured, collected and queried appropriately within agreed specifications.
  • Preparation for Clinical Events adjudication committee meetings.
  • Assisting in writing Clinical Study Reports.
  • Regularly reviewing Clinical and Regulatory documentation.
  • Assisting in setting up and addressing any issues with clinical study agreements.

Skills and Requirements

  • A Bachelor's degree in a scientific or health-related field is required.
  • Formal training in ICH-GCP regulations.
  • Knowledge of GDPR.
  • At least 2 years of clinical study experience, ideally in medical devices.
  • Advanced understanding of GCPs and ICH; European and international (OUS) clinical trial regulations and guidelines.
  • EDC system experience preferred.
  • Experience in auditing, ICH GCP and EU MDR.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Fully proficient in the use of MS Word, Excel, PowerPoint and clinical data management systems.
  • Fluent in German and English.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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