Clinical Research Associate- cell and Gene therapy

Astrazeneca; United Kingdom; À distance; GBP 42 000 - 56 000; Plein temps

Résumé du poste

AstraZeneca plc is seeking a Clinical Research Associate to oversee sites for cell and gene therapy studies in the UK. You will drive start-up, regulatory submissions, and ongoing QC to ensure data integrity and patient safety.

You will train investigators, monitor sites with risk-based approaches, manage CTMS/eT MF updates, and collaborate with MSLs and LSAD. Travel nationally/internationally is required.

Qualifications

• Bachelor degree in life sciences or related discipline; equivalent qualification.

Responsabilités

• Act as primary face of studies at assigned sites from start-up to close-out.
• Train and guide site teams on study requirements and quality management.
• Identify investigators and build a high-performing site network.
• Lead start-up activities and regulatory maintenance (EC/IRB submissions).
• Ensure timely reporting of Serious Adverse Events and regulatory compliance.
• Update CTMS and eTMF; prepare monitoring visit reports and follow-ups.
• Collaborate with local MSLs and LSAD; participate in study team meetings.
• Travel nationally/internationally as required to monitor sites.

Connaissances

ICH-GCP knowledge

Cell & gene therapies

Drug development process understanding

Clinical trial monitoring (late phases

Attention to detail

Written & verbal communication

Collaboration & interpersonal skills

Travel nationally/internationally

Risk-based monitoring

Remote collaboration

Formation

Bachelor degree in life sciences or related discipline

Description du poste

Clinical Research Associate- cell and Gene therapy

As a Clinical Research Associate, you will be the primary face of our studies at assigned sites, ensuring excellence from start-up through close-out. You will collaborate closely with local study leadership and cross-functional partners to uphold the highest standards of quality, compliance and patient safety. Your work will directly influence trial timelines, data integrity and the speed at which new therapies move forward.

In this role, you will bring structure and momentum to complex studies training and guiding site teams, leveraging risk-based approaches, and translating insights from the field into action. You will join a community that pairs scientific rigor with digital and data driven tools, all in service of delivering life-changing medicines to people who need them most.

Accountabilities:

• Contribute to identifying and assessing potential investigators to build a high-performing site network aligned with protocol needs and patient access.
• lead start-up and regulatory maintenance including Site Qualification Visits; collection, preparation, review and tracking of documents; and submissions to EC/IRB and Regulatory Authorities for study start-up and throughout the study.
• Train, support and advise Investigators and site staff on study-specific requirements and Risk Based Quality Management principles; confirm completion and documentation of required training, including ICH-GCP; keep sites inspection-ready at all times.
• Actively participate in Local Study Team meetings and contribute to National Investigators meetings as applicable; share recruitment and site performance insights to drive data-informed decisions and actions.
• Initiate, monitor and close study sites in line with AstraZeneca Procedural Documents and the study-specific Monitoring Plan; perform remote and onsite visits and remote data checks; collaborate with LSAD on visit timing and type when required.
• Perform Source Data Review, Case Report Form review and Source Data Verification per the Monitoring Plan; conduct regular Site Quality Risk Assessments and adapt monitoring intensity accordingly; ensure timely data query resolution and partner with data management to drive robust data quality.
• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups; accelerate systematic or serious quality issues, data privacy breaches and CSP or ICH-GCP compliance issues per local processes; ensure compliance with the Code of Ethics, company policies (including SHE) and local/national/regional legislation.
• Manage study supplies, drug supplies and drug accountability at sites; prepare study drug for destruction where applicable.
• Update CTMS and other systems within required timelines; prepare and finalize monitoring visit reports and follow-up letters in line with SOPs; ensure timely collection and upload of essential documents into the eTMF and support regular QC checks; ensure site documents and communications are ready for archiving and completion of the local eTMF.
• Prepare for and collaborate during audits and regulatory inspections with LSAD and CQAD; assist sites in maintaining an inspection-ready ISF.
• Provide feedback on research-related information including site and investigator insights and competing studies; collaborate with local MSLs as directed by LSAD or line manager.
• Drive site performance by proactively identifying issues, resolving them promptly and escalating appropriately; with tenure and experience, take on additional responsibilities associated with LSAD to broaden your impact.
• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP
• Good knowledge of relevant local regulations.
• Good knowledge and experience of cell and gene therapies
• Understanding of the drug development process.
• Prior experience in monitoring clinical trials in late phases ( 2-4), study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills. Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Ability to work in an environment of remote collaborators.
• Manages change with a positive approach for self, team and the business; sees change as an opportunity to improve performance and add value.
• Ability to champion more efficient and effective methods and processes to deliver quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Familiarity with risk-based monitoring approaches, including remote monitoring.