Clinical Research Associate

hace 6 días


Madrid, Madrid, España Tfs Healthscience A tiempo completo

**Role Overview:**

TFS HealthScience, a leading global Contract Research Organization (CRO), seeks an experienced Clinical Research Associate to join our SRS/FSP team. As a key member of this team, you will be dedicated to supporting a prominent biotech company in onco-hematology trials.

**Job Responsibilities:**

  • Monitor clinical trials in accordance with TFS and client company SOPs, FDA regulations, GCP, and ICH guidelines.
  • Review CRFs and subject documentation for accuracy and validity, generating queries as necessary.
  • Identify site problems and deficiencies, reporting them to management through trip reports and verbal communication.
  • Initiate corrective actions as directed by supervisor.
  • Contribute to the completion of Ethics Committee/IRB applications, preparing necessary documentation.
  • Participate in contract handling and negotiation.
  • Set up and distribute ISF and SMF to investigational sites.
  • Maintain CTMS system with site and study information.
  • Audit data in tables and text of clinical summaries.

**Key Qualifications:**

  • Bachelor's Degree in life science or nursing or equivalent.
  • Minimum 4 years of CRA experience.
  • Oncology studies experience.
  • Ability to work in a fast-paced environment with changing priorities.
  • Understand basic medical terminology and science associated with assigned drugs and therapeutic areas.
  • Familiarity with Good Clinical Practice regulations and ICH guidelines.

**What We Offer:

We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment.

The estimated salary for this position is €60,000 - €80,000 per annum, depending on experience and qualifications.



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