CRA 1 CRA 2 Full Service Operation Model Porto, Portugal
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Main Responsibilities:
Clinical site monitoring: conducts routine prestudy initiation and closeout 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.
Crossfunctional communication & logistics: liaises with internal teams manages study materials and travels as required.
Qualifications required:
University Masters 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 youll join a highly collaborative supportive and growthoriented environment where your development is valued and your contributions truly make an impact
Learn more about our EEO & Accommodations request here.
