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Clinical Research Associate

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DOCS is currently recruiting a number of Clinical Research Associate roles, office-based in Frankfurt area or home-based in Germany. The successful candidates will join established clinical teams seconded to our clients, world-class pharmaceutical and biotechnology companies. This is an exciting opportunity for experienced CRA’s, which offers a competitive package, career growth, and exceptional training and development programmes. Contact us today, to find out more.

Key responsibilities:

  • Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
  • Provide input into feasibility, identify clinical investigators and conducts site evaluations post-feasibility to determine site suitability and selection
  • Conduct Clinical Site Initiation visits
  • Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
  • Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
  • Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
  • Facilitate the resolutions of clinical queries to investigative staff in accordance to the study specific monitoring plan
  • Report Important Protocol Deviations (IPDs) and develop issue resolution plans
  • Review, collect and maintain essential documents, submit to CTA for processing
  • Develop site visit plans and conducts monitoring visits
  • Prepare reports for Investigator and Site Evaluations, Clinical Site Initiation, Clinical Site Monitoring, and Clinical Site Close-Out
  • Assist in preparing sites for audits, review audit reports and contributes to resolve findings
  • Build and maintain solid and long-term professional relationships with investigators and site staff
  • Perform investigational product accountability and reconciliation.
  • Execute clinical supplies management at sites in a compliant manner
  • Mentor new CRAs, as needed
  • Conduct Clinical Site Close-Out visits
  • Travel frequency of up to 60%

Education & Experience

  • Solid experience in working independently as a CRA
  • Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
  • Profound knowledge of clinical trial processes and operations
  • Familiar with ICH/GCP guidelines plus local codes of practice as applicable
  • Attention to detail
  • Organizational skills
  • Relationship management & influencing skills
  • Time management & prioritization
  • Flexibility
  • Proficiency in English and German
  • Problem solver
  • Team worker
Why this vacancy is right for you:

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested? Please submit your CV to przemyslaw.brzezinski@docsglobal.com. We are looking forward to your application.
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