Clinical Research Associate II - Barcelona

Fortrea; Barcelona; Sur place; EUR 42 000 - 56 000; Plein temps

Résumé du poste

Fortrea seeks a Clinical Research Associate to monitor study sites in Catalonia, Spain, ensuring adherence to ICH GCP and regulatory guidelines. You will conduct visits, review data, liaise with vendors, and help keep trial timelines on track.

The role requires at least 2 years of independent monitoring, oncology experience preferred, fluent in Spanish and English, a university degree, and a valid driver’s license. Travel is expected as part of the job.

Qualifications

• University or college degree in a related allied health profession.
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Fluent in Spanish and in English, both written and verbal.
• Fortrea may consider relevant experience in lieu of educational requirements.

Responsabilités

• Site monitoring including routine monitoring, closeout visits, and study file maintenance.
• Liaise with vendors and investigators to support trial timelines.
• Ensure informed consent procedures comply with regulatory requirements.
• Review source data and ensure data integrity in CRFs or data tools.
• Coordinate travel according to Fortrea travel policy and monitor costs.
• Prepare trip reports and interact with cross-functional teams as assigned.
• Support registry management and feasibility activities as requested.
• Assist in QA visits and regulatory submissions as needed.

Connaissances

ICH GCP guidelines

Regulatory knowledge

Spanish language

English language

Project teamwork

Planning & organization

Computer skills

Driver’s license

Formation

University or college degree in allied health

Description du poste

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 18) 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

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