Clinical Research Associate II - Madrid

Fortrea; Madrid; Presencial; EUR 42.000 - 54.000; Jornada completa

Descripción de la vacante

Fortrea is seeking a Site Monitor to oversee clinical study monitoring and site management in Madrid. You will conduct routine visits, ensure protocol and regulatory compliance, and manage study files across sponsored trials, with travel as an essential function.

Requirements include a university degree or equivalent allied health certification, ICH-GCP knowledge, and fluency in Spanish and English. Prior oncology monitoring is preferred, and you will work within a matrix environment at Fortrea.

Formación

• University degree or related allied health certification.
• Thorough understanding of ICH GCP and local regulatory requirements.
• Fluent in Spanish and English, both written and spoken.
• Fortrea may consider equivalent experience in lieu of education.

Responsabilidades

• Manage all aspects of site monitoring including routine visits and closeout.
• Ensure protocol adherence and informed consent according to regulatory requirements.
• Maintain study files and liaise with vendors as assigned.
• Coordinate travel and prepare timely trip reports as required.
• Support feasibility assessments and sponsor communications as needed.

Conocimientos

Fluent Spanish

Fluent English

Computer skills

Educación

Bachelor's degree in related field

Herramientas

Microsoft Office

Descripción del empleo

Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned.

Summary of Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.

General On-Site Monitoring Responsibilities

• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
• Monitor data for missing or implausible data.
• 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.
• Ensure audit readiness at the site level.
• Travel, including air travel, may be required and is an essential function of the job. 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 (vendors) as assigned.
• Responsible for all aspects of registry management as prescribed in the project plans.
• Undertake feasibility work when requested.
• Participate in and follow-up on Quality Control Visits (QC) when requested.
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
• Assist Senior CRA with managing investigator site budgets.
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.

Qualifications (Minimum Required)

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

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

Fluent in Spanish and in English, both written and verbal.

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

Experience (Minimum Required)

Minimum 2 years of experience as independent monitor.

Previous monitoring experience in Oncology clinical trials is highly preferred.

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.

Works efficiently and effectively in a matrix environment.

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.