Clinical Research Associate

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 We are looking forward to your application.
While applying for the job please refer to jobvector

About DOCS International Germany GmbH

DOCS International ist eine internationale Staffing Company für die Healthcare- Industrie. Hier bieten wir für unsere Kunden - namhafte Pharmaunternehmen, Biotechnologieunternehmen und CRO's - internationale Dienstleistungen an. Diese umfassen zum einen die Vermittlung von Fach- und Führungskräften an unsere Kunden, zum anderen die Rekrutierung eigner DOCS...

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