Clinical Research Associate II - FSP Model at Fortrea

Madrid, Community of Madrid, Spain -

Full Time

Start Date

Immediate

Expiry Date

28 Feb, 26

Salary

0.0

Posted On

30 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Monitoring, Site Management, Regulatory Compliance, Data Integrity, Eligibility Reviews, Informed Consent, Source Document Review, Project Management, Analytical Skills, Negotiation Skills, e-Clinical Systems, Oncology Expertise, Hematology Expertise, CAR-T Expertise, SNC Expertise, Hospital Experience

Industry

Biotechnology Research

Description

Summary of Responsibilities: Site management for clinical studies is conducted in accordance with Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans, and sponsor requirements. This includes verifying that study training records are complete and accurate. Site monitoring responsibilities cover all phases of a clinical trial—Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits—ensuring compliance with regulatory and protocol standards. Project plans related to clinical monitoring are prepared and implemented to align with study timelines and deliverables. Subject protection is ensured through eligibility reviews and verification that informed consent procedures and protocol requirements are followed in accordance with regulatory expectations. Data integrity is safeguarded through thorough source document review, source data verification, query generation and resolution, all performed using Fortrea or sponsor data management systems. Site regulatory documentation and eTMF/Sponsor files are maintained to be complete and current throughout the trial duration, ensuring audit readiness. Investigational Product inventory and accountability are confirmed to be accurate, with secure storage and handling per protocol. Additional responsibilities include supporting CRA performance metrics, acting as Lead CRA when assigned, and collaborating with study teams to meet project goals. 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. 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). AND a minimum of 2 years of Clinical Monitoring experience. Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. Therapeutic area’ expertise required: expertise in oncology and hematology, CAR-T and SNC. Additional expertise in other areas is a plus. Sites expertise: preferably experience and very used to work at the Hospital of Salamanca. Preferred Qualifications Include: Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. Good analytical and negotiation skills. Experience using e-clinical systems [e.g., clinical trial management system (CTMS)]. Physical Demands/Work Environment: Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites). Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. 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.

Responsibilities

The Clinical Research Associate II is responsible for site management of clinical studies, ensuring compliance with regulatory and protocol standards throughout all phases of a clinical trial. This includes monitoring site activities, maintaining regulatory documentation, and safeguarding data integrity.