Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Italy for its expanding international hematology/oncology clinical trials program.
This is a full-time position.
Job overview:
The CRA is responsible for ensuring the conduct of clinical trials at selected investigational sites complies with approved protocols, ICH GCP guidelines, SOPs, and applicable laws. The CRA acts as the primary communication link between the sponsor, investigators, and study personnel, ensuring the rights of subjects are protected and data integrity is maintained.
Main responsibilities:
* Ensure compliance with company quality and information security systems, ICH GCP, and relevant legislation, including data protection laws.
* Report deviations from protocols or regulations to management.
* Conduct pre-study visits to evaluate potential sites.
* Coordinate with regulatory and clinical teams for submissions and contracts.
* Explain study procedures to investigators and provide training.
* Maintain and update clinical trial files and ensure proper documentation.
* Oversee study medication supply, storage, and accountability.
* Monitor site activities to ensure protocol adherence and data accuracy.
* Verify informed consent and safety reporting.
* Manage study documentation, reporting, and communication with sites.
* Participate in audits and inspections, facilitating corrective actions.
* Assist in site feasibility, screening, and selection processes.
* Support study financials and subject recruitment efforts.
* Participate in planning, SOP development, and team coaching.
Job requirements:
* Bachelor’s or master’s degree in Health Sciences preferred.
* Certified CRA.
* 6-12 months of CRA experience.
* Fluent in English and Italian (oral and written).
* Completed an ICH GCP training course (desirable).
* Proficient in computer skills.
* Strong communication and organizational skills.
* Ability to work independently and as part of a team.
* Effective communication skills and ability to handle stressful situations.
* Willingness to travel frequently, including international trips.
Join our multidisciplinary team of scientists and healthcare professionals in the exciting field of clinical research. We offer a competitive remuneration package.
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