Key Facts

Remote From:

Full time

Junior (1-2 years)

English

Hard Skills

Clinical Monitoring Regulatory Compliance Safety Audits Data Management Data Quality Assessment Digital File Management Budget Management Vendor Management Feasibility Studies Protocol Implementation Conformance Statement +7 more

Other Skills

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Training And Development
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Computer Literacy
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Communication
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Teamwork
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Organizational Skills
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Detail Oriented

Roles & Responsibilities

Master's degree in healthcare or a related field
Minimum 1 year of experience as a CRA
Foundational knowledge of the clinical trial process and regulatory guidelines
Fluency in English and the local language (written and spoken) with proficiency in standard computer software

Requirements:

Conduct routine, pre-study, initiation, and close-out site visits to ensure protocol and project plan compliance
Perform data quality oversight including source data verification, CRF review, and management of data queries
Oversee operational site activities such as trip reports, audit readiness, study file management, and vendor coordination
Monitor safety by tracking and following up on SAEs and assisting with safety reporting narratives

Job description

Our FSO department in Portugal is looking for a CRA I / II to manage clinical studies principally in Oncology, Hematology and Immunology .

Home based in Porto area.

Main Responsibilities:

Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.
Site and patient protection: ensures informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
Data quality oversight: performs source document verification, CRF review, and manages data queries to ensure accuracy and completeness.
Operational site management: prepares trip reports, ensures audit readiness, manages study files, coordinates with vendors, and uses resources efficiently.
Safety reporting: tracks and follows up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
Extended support activities: feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
Cross‑functional communication & logistics: liaises with internal teams, manages study materials, and travels as required.

Qualifications required:

University Master's degree in healthcare or similar.
Basic understanding of the clinical trial process and foundational knowledge of applicable regulatory guidelines.
Fluency in both English and the local office language, in written and verbal communication.

Experience (Minimum Required):

• Mandatory 1 year minimum of experience as CRA.

• Understanding of Regulatory Guidelines.

• Good computer skills with good working knowledge of a range of computer packages.

By stepping into this role, you’ll join a highly collaborative, supportive, and growth‑oriented environment where your development is valued and your contributions truly make an impact

Learn more about our EEO & Accommodations request here.