Description
Fortrea's FSP team is currently seeking a CRA II professional to join the team in Galicia with specific experience in General Medicine. This is a permanent, full-time role.
Job Summary: As a CRA II, you will be responsible for conducting clinical site monitoring, ensuring compliance with project plans, and protecting site and patient safety.
Key Responsibilities:
- Conduct routine, pre-study, initiation, and close-out visits to ensure full compliance with project plans.
- Ensure informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
- Perform source document verification, CRF review, and manage data queries to ensure accuracy and completeness.
- Prepare trip reports, ensure audit readiness, manage study files, coordinate with vendors, and use resources efficiently.
- Track and follow up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
- Participate in feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
- Liaise with internal teams, manage study materials, and travel as required.
Requirements:
- 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 2 years of experience as an independent monitor, working specifically within general medicine: Immunology, Cardiology, Hypertension, Diabetes, or Ophthalmology.
- Basic understanding of Regulatory Guidelines.
- Ability to work within a project team.
- Good planning, organization, and problem-solving skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Valid Driver's License.