Clinical Research Associate Andalucia
hace 2 semanas
**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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