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Clinical Research Associate (Home based Sevilla)

Location Madrid, Madrid, Spain Job ID R-085888 Date posted 07/03/2020

At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.

As Clinical Research Associate (CRA) you will be responsible for the delivery of the studies at allocated investigator sites and will active participate in the local study team(s). You will work in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.

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.

Accountabilities

  • Contributes to the selection of potential investigators.
  • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
  • 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.  Ensures the sites are inspection ready at all times.
  • Actively participates in Local Study Team (LST) meetings.
  • Contributes to the selection of potential investigators.
  • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
  • 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.  Ensures the sites are inspection ready at all times.
  • Actively participates in Local Study Team (LST) meetings.
  • Contributes to National Investigators meetings, as applicable.
  • Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
  • Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
  • Updates CTMS and other systems with data from study sites as per required timelines.
  • Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
  • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
  • 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.
  • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
  • 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 up on outstanding actions with study sites to ensure resolution in a timely manner.
  • 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.
  • Assists site in maintaining inspection ready ISF.
  • Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
  • 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.
  • Ensures that all study documents under their responsibility (i.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.

Essential Requirements

  • Bachelors degree in related discipline, preferably in life science.
  • Experience as CRA from either a pharmaceutical company or a CRO of at least 2-3 years is required.
  • Location Sevilla.
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  • Fluent knowledge of spoken and written English: B2.2.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge and ability to learn relevant AZ Therapeutic Areas .
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, 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. 

Desirable Requirements

  • 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 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.
  • Oncology knowledge.
  • Good analytical and problem-solving skills.
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
  • 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.
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Key stakeholders and relationships

Internal (to AZ or team)

  • LSMs and Local Study Teams
  • Line Manager (ADSMM and local SMM LT)
  • Clinical Quality Manager
  • Local Medical Teams: MSLs and Medical Affairs
  • Global Study Team
  • Enablement functions
  • Clinical Data Management
  • Regulatory Affairs
  • Patient Safety

External (to AZ)

  • Investigators and site personnel
  • Study related vendors
  • Inspectors

Los requisitos para que los candidatos puedan optar a una convocatoria interna son: llevar 1 año en su posición actual, mantener informado a su responsable directo de su participación en el proceso, no tener establecido un Plan  Mejora vigente.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.



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 authorisation and employment eligibility verification requirements.

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