Clinical Research Associate Andalucia

hace 2 semanas


Sevilla, Sevilla, España Tfs Healthscience A tiempo completo

**Job Summary:**

Tfs Healthscience is seeking an experienced Clinical Research Associate (CRA) to join our team in Andalucia, Spain. As a CRA, you will be responsible for monitoring clinical trials in accordance with Tfs and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines.

Key Responsibilities:

  • Monitor on-site and remotely clinical trials, ensuring compliance with regulatory requirements and company standards.
  • Review CRFs and subject source documentation for validity and accuracy, generating queries to investigational sites as needed.
  • Identify site problems/deficiencies and report them to management through trip reporting, memos, and verbal communication.
  • Contribute to the completion of ethics committee/IRB applications, preparing necessary documentation according to local requirements.
  • Participate in contract handling and negotiation, coordinating with project managers and other stakeholders.
  • Set up ISF and SMF systems, distributing them to investigational sites and maintaining their integrity.
  • Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
  • May prepare and submit status reports, reviewing and supporting site staff to maintain SMF.
  • Review informed consent documents for essential elements and protocol specifics.
  • Update CTMS system with site and study information.

Qualifications:

  • Bachelor's degree in life science or nursing, or equivalent experience.
  • Minimum 1-2 years of experience working as a CRA (oncology).
  • Able to work in a fast-paced environment with changing priorities.
  • Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas.
  • Possess knowledge of Good Clinical Practice regulations, ICH guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work independently and as part of a team matrix organization.

Salary and Benefits:

We offer a competitive compensation package, including a salary range of €35,000-€45,000 per year, depending on experience, plus comprehensive benefits and opportunities for personal and professional growth in a rewarding environment.

About Us:

Tfs Healthscience is a leading global Contract Research Organization (CRO), partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and functional service (FSP) solutions.

Location:

Andalucia, Spain (Sevilla/Málaga)

Working Conditions:

This role requires regular travel, up to 60-70% of the time, with potential international assignments.



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