Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Ireland for its growing international hematology/oncology Clinical Trials program.
This is a full-time job.
Right to work in the UK and Ireland is a must
Job overview
The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP guidelines, the applicable Standard Operating Procedures (SOPs) and the applicable laws and regulations.
He/she is the primary responsible person for communication on operational study related activities between the Sponsor, the Investigator and other study personnel to build and maintain successful working relationships.
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.
Main responsibilities
- Conduct site feasibility, selection, initiation, monitoring, and close-out visits across the UK and Ireland, ensuring compliance with study protocols, ICH-GCP guidelines, SOPs, and applicable regulations.
- Serve as the primary point of contact between investigational sites and the Sponsor, building strong relationships with investigators and study teams.
- Train and support investigators and site personnel on study protocols, trial procedures, safety reporting requirements, and GCP compliance.
- Perform source data verification (SDV), review eCRFs, verify informed consent processes, and ensure the accuracy, completeness, and integrity of clinical trial data.
- Manage and maintain essential study documentation, including Investigator Site Files and Clinical Trial Files, ensuring inspection readiness throughout the study lifecycle.
- Coordinate regulatory and ethics committee submissions, approvals, study contracts, and other site-related documentation in collaboration with internal teams.
- Oversee investigational product management, including drug accountability, storage, dispensing, shipment, return, and destruction activities.
- Monitor patient recruitment, enrollment, retention, and study timelines, proactively identifying and addressing site performance issues.
- Ensure timely reporting and documentation of safety information, protocol deviations, and study-related issues in accordance with regulatory and company requirements.
- Prepare monitoring visit reports, follow-up communications, and study updates, while participating in project meetings and providing feedback to study management.
- Support audit and inspection readiness activities and collaborate with Quality and Clinical Operations teams to implement corrective and preventive actions when required.
- Contribute to feasibility assessments, departmental initiatives, SOP development, and mentoring of junior CRAs as needed.
Job Requirements
- Bachelor's and/or Master's degree, preferably in Health Sciences or a related field.
- Minimum of 6-12 months' experience as a Clinical Research Associate (CRA).
- Excellent verbal and written communication skills in English.
- ICH-GCP training certification is desirable.
- Proficient in Microsoft Office and other relevant clinical research systems.
- Strong communication, interpersonal, and relationship-management skills.
- Excellent organizational skills with strong attention to detail.
- Ability to work independently while contributing effectively within a collaborative team environment.
- Capable of communicating professionally and diplomatically with investigators, site personnel, and cross-functional stakeholders.
- Able to manage multiple priorities, adapt to changing timelines, and perform effectively in a fast-paced environment.
- Strong problem-solving skills with the ability to maintain oversight of multiple study activities simultaneously.
- Demonstrated commitment to working in accordance with SOPs, regulatory requirements, GCP guidelines, and ethical standards.
- Willingness and ability to travel frequently, including local and international travel, overnight stays, and occasional evening commitments.
- Availability to monitor clinical trial sites across the UK and Ireland.
- Must have the right to work in the UK and Ireland
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.