Clinical Research Associate Fixed Term Contract (m,w,d)

at  AstraZeneca

ACCOUNTABILITIES:

• Contributes to the selection of potential investigators.
• CRAs are accountable for site start-up. Tasks include Site Qualification Visits, collection, review and tracking of documents for the application process.
• 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 , prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
• Supports sites in enhancing patient recruitment
• Acts as Site Manager supporting the site in relevant study related topics
• Actively participates in Local Study Team (LST) meetings.
• Initiates, monitors and closes study sites in compliance with the Clinical Study Protocol. Shares information on patient recruitment and study site progress (site quality/performance) within the LST
• Contributes to National Investigators meetings, as applicable.
• Collaborates with local MSLs as directed by LSAD or line manager.

ESSENTIAL SKILLS/EXPERIENCE:

• Bachelor degree in related field, preferably in life science, or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• 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.
• Excellent collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license.

DESIRABLE SKILLS/EXPERIENCE:

• Ability to work in an environment of remote collaborators.
• Good analytical and problem-solving skills.
• 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 digital literacy while making appropriate use of systems/software in an enabled environment.

Join us as a Clinical Research Associate at AstraZeneca, where you will play a pivotal role in ensuring the high-quality conduct of clinical trials in Austria. You will be responsible for the delivery of studies at allocated sites and will act as the main contact with the study site, ensuring accurate delivery of the study in Austria. This role offers an opportunity to work closely with other CRAs and the Local Study Team to ensure that study commitments are achieved in a timely and efficient manner.