Clinical Research Associate

Introduction to role:

This role is based in Barcelona with an on-site commitment of three days a week. Fluency in English is required.

As a Clinical Research Associate (CRA) within AstraZenecas Oncology Cell Therapy Clinical Operations you will have local responsibility for the delivery of clinical studies at assigned sites and serve as the primary point of contact for investigators and site staff. You will work closely with Local Study Teams and the Local Study Associate Director (LSAD) to ensure timely high-quality execution in alignment with ICH-GCP local regulations and AstraZeneca procedural documents. Leveraging risk-based quality management principles you will prepare initiate monitor and close sites ensuring inspection readiness and robust data quality across our innovative oncology cell therapy portfolio.

Accountabilities:

• Site identification and start-up: Contribute to investigator/site applicable countries lead start-up and regulatory maintenance including qualification visits dossier preparation submissions to EC/IRB and Regulatory Authorities and tracking essential documents.

• Training and inspection readiness: Train and advise investigators and site staff on protocol and RbQM. Confirm and document mandatory trainings (including ICH-GCP) and maintain inspection-ready site files at all times.

• Study conduct and performance: Initiate monitor (onsite/remote) and close sites per Monitoring Plan and SOPs; share recruitment and site performance insights with Local Study Teams; proactively identify resolve and escalate study issues.

• Monitoring and data quality: Perform SDR SDV and CRF review; adapt monitoring intensity via regular Site Quality Risk Assessments; ensure timely query resolution and collaborate with data management for high-quality data.

• Safety and compliance: Secure accurate and timely reporting of SAEs and follow-ups; ensure compliance with AZ Code of Ethics SOPs ICH-GCP data privacy requirements and applicable legislation.

• Systems and documentation: Update CTMS and other systems per timelines; manage study supplies and drug accountability (including destruction preparation); prepare monitoring visit reports and follow-up letters; collect/upload essential documents to eTMF and support QC checks; ensure documentation is complete for archiving.

• Audit/inspection support: Prepare for and collaborate on audit and regulatory inspection activities with LSAD and Clinical Quality.

• Cross-functional collaboration: Work with LSADs local medical teams (e.g. MSLs) and global study teams/vendors as directed; provide market and site intelligence relevant to oncology cell therapy studies.

Essential Skills/Experience:

• Education: Bachelors degree in a related discipline (preferably life sciences) or equivalent qualification.

• Guidelines and regulations: Excellent knowledge of ICH-GCP; good knowledge of relevant local regulations; basic knowledge of GMP/GDP.

• Clinical operations: Solid understanding of clinical study management including monitoring (onsite/remote) study drug handling and data management; familiarity with risk-based monitoring and remote monitoring practices.

• Technical and analytical: Strong attention to detail; good analytical and problem-solving skills; ability to use e-enabled systems (CTMS eTMF EDC) and adapt to new technologies.

• Communication and collaboration: Good written and verbal communication; effective interpersonal and negotiation skills; ability to work with remote collaborators and in cross-functional teams.

• Delivery focus: Demonstrated ability to prioritize and manage multiple tasks with conflicting deadlines; proactive issue identification and resolution; ability to travel nationally/internationally as required.

• Professional conduct: Commitment to inspection readiness patient safety reporting data privacy and adherence to AZ Code of Ethics and SHE requirements.

Desirable Skills/Experience:

• Therapeutic area exposure: Medical knowledge and learning agility in oncology; interest or experience in cell therapy or advanced therapies.

• Process excellence: Experience championing efficiencies to deliver quality trials with reduced budget and timelines; change agility and continuous improvement mindset.

• Cultural awareness: Ability to work effectively across diverse sites and geographies.

• Additional qualifications: Valid driving license (where required by country); experience contributing to investigator meetings and audits/inspections; ability to support LSAD tasks as needed.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca we are driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline we are empowered to lead at every level. We make bold decisions driven by patient outcomes collaborating seamlessly with academia and industry to expedite research in some of the hardest-to-treat cancers. Join us in making a meaningful impact on millions of lives.

Ready to take the next step in your career Apply now and become part of our dynamic team!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.