Clinical Research Associate The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager. CRAs might have different internal titles based on the experience level (Associate CRA, CRA, Senior CRA).

The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The SMM Country Head may assign this internal title after confirmation with Cluster Director SMM/Senior Director SMM (Region). Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.

Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Actively participates in Local Study Team (LST) meetings.



Shares information on patient recruitment and study site progress (site quality/performance) within the LST.

Drives performance at the sites. Updates CTMS and other systems with data from study sites as per required timelines. Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan.

Performs Source Data

Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. Ensures data query resolution in a timely manner.

Works with data management to ensure robust quality of the collected study data. Prepares and finalises monitoring visit reports in CTMS and provides timely feed‐back to the Principal Investigator, including follow‐up letter, within required timelines and in line with AZ SOP. Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH‐GCP compliance issues to Local Management and/or CQM as required.

Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH‐GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate. E. site documents, relevant communications, etc)



are available and ready for final archiving and completion of local part of the eTMF.

Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Ensures compliance with AstraZeneca's Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). Ensures compliance with local, national and regional legislation, as applicable.

Collaborates with local MSLs as directed by LSM or line manager. Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*). Good knowledge of relevant local regulations.

Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Ability to work in an environment of remote collaborators. Sees change as an opportunity to improve performance and add value to the business.

Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Familiar with risk‐based monitoring approach including remote monitoring. Good cultural awareness.

Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e‐enabled environment. ability to respond quickly to shifting demands and opportunities. LSMs and Local Study Teams Line Manager (ADSMM and local SMM LT) Clinical Quality Manager Local Medical Teams: MSLs and Medical Affairs Integral Study Team Clinical Data Management We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

📌 Research Associate (Galicia)
🏢 AstraZeneca
📍 Galicia