Clinical Research Excellence
Senior Clinical Research Associate
Location
Portugal
Posted
18 hours ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
TFS HealthScience - Contract Research Organization
• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations • Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality • Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations • Review CRFs (electronic or paper) and subject source documentation for validity and accuracy • Verify proper management and accountability of Investigational Product • Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate • Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner • Timely delivering site documents to eTMF or paper TMF • Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements
Job Requirements
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- >3 years of experience as CRA including relevant on-site monitoring experience
- Able to work in a fast-paced environment with changing priorities
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
Benefits
- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
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