Clinical Research Associate
4 days ago
Athens, Attica, Ελλάδα
Veeda Lifesciences
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Συνεχίζοντας, αποδέχεστε: Όροι χρήσης & Πολιτική απορρήτου.
Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Athens, Greece for its growing international hematology/oncology Clinical Trials program.
The position is offered on a freelance basis.
Job overview:
As a CRA, you will play a critical role in ensuring clinical trials are conducted in compliance with ICH-GCP, protocols, SOPs, and regulatory requirements, while safeguarding patient safety and data integrity. The most important responsibility is to ensure that the subjects’ rights are respected and that all collected clinical trial data are accurate, complete, and verifiable from source documents.
You will act as the primary liaison between Sponsor and Investigational Sites, building strong relationships and ensuring smooth trial execution.
Main
responsibilities:
• Ensure full compliance with ICH-GCP, SOPs, data protection laws, and regulatory requirements
• Identify and report protocol deviations in accordance with internal procedures
• Conduct feasibility, site selection, and pre-study visits, evaluating site capabilities and resources
• Collaborate with Regulatory Affairs and Clinical Operations on: IEC/IRB submissions and approvals and Study contracts and financial documentation
• Train and support investigators and site staff on protocol, procedures, and GCP requirements
• Prepare, maintain, and update Clinical Trial Files and Investigator Site Files (ISF)
• Ensure proper study drug management, including shipment, storage, dispensing, return, and destruction
• Perform on-site and remote monitoring visits, including: Source Data Verification (SDV) per monitoring plan / Verification of informed consent processes / Oversight of recruitment, timelines, and site performance/ Review of investigator qualifications and site resources
• Ensure accurate and timely safety reporting (AE/SAE) and proper site training
• Verify timely submissions to IEC/IRB and regulatory authorities
• Perform and oversee drug accountability at site level
• Prepare detailed monitoring visit reports and maintain ongoing communication with sites
• Participate in study meetings and provide updates to CRA Management
• Support audit and inspection readiness, including CAPA follow-up
• Contribute to site feasibility, selection, and patient recruitment strategies
• Support study financial processes, including investigator payments
• Ensure timely patient enrolment and high-quality data collection
• Optimize recruitment performance in line with study targets
• Conduct site close-out activities at study completion
• Participate in departmental initiatives, including SOP development
• Provide mentoring and guidance to junior CRAs, as needed Job
Requirements:
• Bachelor’s degree in Life Sciences, Health Sciences, or related field; Master’s degree preferred.
• Minimum 6–12 months of previous experience as a CRA
• Excellent command of Greek and English, both written and spoken.
• Attendance of an ICH GCP training course is desirable.
• Strong computer skills and proficiency in clinical data systems.
• Excellent communication, organizational, and interpersonal skills.
• Ability to work independently, while effectively collaborating in a team environment.
• Strong diplomatic and effective communication skills with study site personnel.
• Ability to handle stressful situations, flexible timelines, and multiple priorities simultaneously.
• Ability to adhere strictly to SOPs, guidelines, regulations, and ethical principles in daily practice.
• Willingness and ability for frequent local and international travel, including evenings and overnight stays. Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.
responsibilities:
• Ensure full compliance with ICH-GCP, SOPs, data protection laws, and regulatory requirements
• Identify and report protocol deviations in accordance with internal procedures
• Conduct feasibility, site selection, and pre-study visits, evaluating site capabilities and resources
• Collaborate with Regulatory Affairs and Clinical Operations on: IEC/IRB submissions and approvals and Study contracts and financial documentation
• Train and support investigators and site staff on protocol, procedures, and GCP requirements
• Prepare, maintain, and update Clinical Trial Files and Investigator Site Files (ISF)
• Ensure proper study drug management, including shipment, storage, dispensing, return, and destruction
• Perform on-site and remote monitoring visits, including: Source Data Verification (SDV) per monitoring plan / Verification of informed consent processes / Oversight of recruitment, timelines, and site performance/ Review of investigator qualifications and site resources
• Ensure accurate and timely safety reporting (AE/SAE) and proper site training
• Verify timely submissions to IEC/IRB and regulatory authorities
• Perform and oversee drug accountability at site level
• Prepare detailed monitoring visit reports and maintain ongoing communication with sites
• Participate in study meetings and provide updates to CRA Management
• Support audit and inspection readiness, including CAPA follow-up
• Contribute to site feasibility, selection, and patient recruitment strategies
• Support study financial processes, including investigator payments
• Ensure timely patient enrolment and high-quality data collection
• Optimize recruitment performance in line with study targets
• Conduct site close-out activities at study completion
• Participate in departmental initiatives, including SOP development
• Provide mentoring and guidance to junior CRAs, as needed Job
Requirements:
• Bachelor’s degree in Life Sciences, Health Sciences, or related field; Master’s degree preferred.
• Minimum 6–12 months of previous experience as a CRA
• Excellent command of Greek and English, both written and spoken.
• Attendance of an ICH GCP training course is desirable.
• Strong computer skills and proficiency in clinical data systems.
• Excellent communication, organizational, and interpersonal skills.
• Ability to work independently, while effectively collaborating in a team environment.
• Strong diplomatic and effective communication skills with study site personnel.
• Ability to handle stressful situations, flexible timelines, and multiple priorities simultaneously.
• Ability to adhere strictly to SOPs, guidelines, regulations, and ethical principles in daily practice.
• Willingness and ability for frequent local and international travel, including evenings and overnight stays. Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.