Clinical Research Associate (CRA I/II) – Phase I Trials – Portugal

On-site

Responsibilities

Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.

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.
Mandatory 2 year minimum of experience as CRA.
Mandatory experience in Phase I trials.
Understanding of Regulatory Guidelines.
Good computer skills with good working knowledge of a range of computer packages.

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.
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 .