Clinical Research Associate II - FSP Team - Portugal

Fortrea; Oeiras; Presencial; EUR 35 000 - 55 000; Tempo integral

Resumo da oferta

Fortrea Portugal seeks an experienced Clinical Monitor to oversee site management and monitoring activities for oncology studies in the Lisbon area. You will ensure ICH-GCP compliance, verify informed consent, perform source data verification, and maintain audit readiness while collaborating with global teams.

Candidates should have at least 2 years independent monitoring experience in Portugal and an accredited degree. Fluent English and local language are required.

Qualificações

• 2 years minimum experience as independent monitor in Portugal oncology studies.
• University or college degree, or certification in a related allied health profession from an accredited institution.
• Fluent in local language and in English, both written and verbal.

Responsabilidades

• Site management for clinical studies following Fortrea SOPs, ICH GCP, and Sponsor requirements.
• Conducts site monitoring including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Ensures protection of subjects by verifying informed consent and protocol adherence.
• Safeguards data integrity through source document review, SDV, and resolution per data review guidelines.
• Confirms Site Regulatory documents and eTMF/Sponsor documents are complete and current; maintains audit readiness.

Conhecimentos

Independent monitor experience

ICH GCP knowledge

Regulatory compliance

English fluency

Oncology familiarity

Formação académica

University degree or nursing certification

Ferramentas

eTMF systems

Data review platforms

Descrição da oferta de emprego

Main 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.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.Ensures audit readiness at site level.Qualifications (Minimum Required):2 years minimum of experience as independent monitor with centers in Portugal, specifically in oncology studies.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.Fluent in local office language and in English, both written and verbal.If you're looking to grow your career within a global organization while working in a collaborative FSP environment, we'd love to hear from you. At Fortrea, you'll have the opportunity to contribute to meaningful clinical research, work alongside industry-leading experts, and help bring innovative therapies to patients worldwide.Apply today and join Fortrea's FSP team in Portugal, where your expertise can make a real difference in advancing healthcare!Learn more about our EEO & Accommodations request here .