Description
Fortrea's FSP team is currently seeking two CRA II professionals to join the team in Madrid.
The successful candidates will have at least 3-4 years of experience working on complex clinical trials, specifically within oncology: early phases/lung phase I/immunology/Gastrointestinal-Prostate-Bladder and renal cancer.
Responsibilities:
- Monitor study sites, including routine monitoring and closeout of clinical sites, maintenance of study files, and conduct of pre-study and initiation visits
- Liaise with vendors and perform other duties as assigned
- Ensure study staff have received proper materials and instructions to safely enter patients into the study
- Verify that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements
- Review source documents to ensure data integrity
- Monitor data for missing or implausible data
- Ensure audit readiness at the site level
- Travel, including air travel, may be required
- Prepare accurate and timely trip reports
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers
- Manage registry management as prescribed in project plans
- Undertake feasibility work when requested
- Participate in and follow-up on Quality Control Visits
- Recruit potential investigators, prepare EC submissions, and notify regulatory authorities
- Assist Senior CRA with managing investigator site budgets
- Track and follow-up on Serious Adverse Event reporting
- Independently perform CRF review and query generation and resolution
Qualifications:
- University degree in a scientific or medical field
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements in Spain
- Fluent in Spanish and English, both written and verbal
Experience:
- Minimum 3-4 years of experience as an independent monitor, working specifically within oncology
- Basic understanding of Regulatory Guidelines
- Ability to work within a project team
- Good planning, organisation, and problem-solving skills
- Good computer skills with good working knowledge of a range of computer packages
- Valid Driver's License