Clinical Research Associate II – Regionalized Galicia - General Medicine

Fortrea; Madrid; On-site; EUR 42,000 - 62,000; Full time

Job summary

Fortrea is seeking a CRA II with General Medicine expertise to join the FSP team in Spain. The role is permanent and involves site visits, regulatory compliance, and data quality oversight across studies.

You will monitor sites, ensure patient safety, support regulatory submissions, and mentor junior staff while traveling as required. Fluency in Spanish and English is required along with 2+ years of independent monitoring experience.

Qualifications

• Bachelor-level or higher degree in science/medicine.
• ICH GCP knowledge and local regulatory awareness (Spain).
• Fluency in Spanish and English, both written and verbal.
• Minimum 2 years of independent monitoring experience in General Medicine.

Responsibilities

• Conduct routine, pre-study, initiation and close-out visits to sites.
• Ensure informed consent, protocol adherence and participant safety.
• Perform source data verification and CRF reviews; manage data queries.

Skills

General medicine

Clinical monitoring

Study coordination

Problem solving

Education

University Degree in Scientific / Medical Field

Job description

Fortrea's FSP team is currently seeking a CRA II professionals to join the team in Galicia with specific experience in General Medicine, this is a permanent role.

Summary of Responsibilities:

• Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.
• Site and patient protection: ensures informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
• Data quality oversight: performs source document verification, CRF review, and manages data queries to ensure accuracy and completeness.
• Operational site management: prepares trip reports, ensures audit readiness, manages study files, coordinates with vendors, and uses resources efficiently.
• Safety reporting: tracks and follows up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
• Extended support activities: feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
• Cross‑functional communication & logistics: liaises with internal teams, manages study materials, and travels as required.

Qualifications (Minimum Required):

• University Degree in Scientific / Medical Field Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements in Spain Fluent in Spanish and in English, both written and verbal.
• Experience (Minimum Required): Minimum 2 years of experience as 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.

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.