Clinical Research Associate II - Immunology - FSP Team Madrid

FTSPA Fortrea Spain S.A; Madrid; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

Fortrea Spain is seeking an experienced Clinical Monitor to manage site activities for immunology trials, ensuring adherence to ICH GCP, SOPs, and sponsor requirements. You will oversee training verification, source data verification, and regulatory documentation while coordinating with the study team.

The role requires 3–4 years of monitoring experience, fluency in English and local language, and willing travel to sites as needed. Strong focus on data integrity and patient safety.

Formación

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
• A minimum of 3–4 years of Clinical Monitoring experience in Immunology clinical studies.
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Fluent in local language and in English, both written and verbal.

Responsabilidades

• Site management for clinical studies per SOPs, ICH GCP, project plans and sponsor requirements.
• Performs site monitoring activities including Pre-study, SI, Process Monitoring, Routine Monitoring and Close-out visits.
• Ensures informed consent and protocol adherence, regulatory compliance, and data integrity.
• Verifies source documents, 100% SDV where applicable, and generates resolutions for data queries.
• Maintains site regulatory documents and oversight of trial material inventory and storage.

Conocimientos

ICH GCP knowledge

Monitoring procedures

English fluency

Local language skills

Educación

University degree or allied health certification

Herramientas

eCRF systems

Descripción del empleo

Summary of Responsibilities

Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.

Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.

Prepares and implements project plans related to Clinical Monitoring responsibilities.

Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.

Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.

Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.

Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.

Ensures adherence to global quality control and CRA performance metrics.

Ensures audit readiness at site level.

Acts in the project role of a Lead CRA as assigned.

General On-Site Monitoring Responsibilities

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study.

Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

Ensure the integrity of the source data reported by careful source document review.

Monitor data for missing or implausible data.

Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.

Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.

Travel, including air travel, may be required and is an essential function of the job.

Prepare and submit accurate and timely trip reports.

Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.

Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.

Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.

Track IP shipments and supplies, as needed.

Track and follow-up on serious adverse events as assigned.

Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.

Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.

Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.

Present training content for site initiation.

Assist with training of new employees (e.g., co-monitoring).

All other duties as needed or assigned.

Qualifications (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).

An equivalent amount of experience can be substituted as appropriate.

Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.

Thorough knowledge of monitoring procedures.

Basic understanding of the clinical trial process.

Fluent in local office language and in English, both written and verbal.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).

A minimum of 3 / 4 years of Clinical Monitoring experience in Immunology clinical studies.

Company Culture

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.