Our FSP department in Spain is looking for a CRA II to work for one of our sponsor and managing clinical studies in Oncology Hematology and Immunology . Full remote role you need to be based in Galicia preferably in Santiago de Compostela and La Coruña.
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 2 years experience in the role.
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.
Required Experience:
IC
Our FSP department in Spain is looking for a CRA II to work for one of our sponsor and managing clinical studies in Oncology Hematology and Immunology . Full remote role you need to be based in Galicia preferably in Santiago de Compostela and La Coruña.Main Responsibilities: Clinical site monitoring...
Our FSP department in Spain is looking for a CRA II to work for one of our sponsor and managing clinical studies in Oncology Hematology and Immunology . Full remote role you need to be based in Galicia preferably in Santiago de Compostela and La Coruña.
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 2 years experience in the role.
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.
Required Experience:
IC
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