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

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 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.

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