Senior Clinical Research Associate - Oncology

at  AstraZeneca

AstraZeneca is a global, biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases.
At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
As a CRA you will have responsibility for the delivery of the local studies at allocated sites and you will be an active participant in the study team(s). You will work 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. You will act as the main contact with the study site and have the responsibility for supervising the study conduct to ensure proper delivery of the study.
You will be responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with internal 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.

THE SENIOR CRA WILL USUALLY HAVE THESE ACCOUNTABILITIES:

• 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 local study teams.
• Builds and maintains professional relationship with key partners within AZ as well as the investigators and study site personnel;
• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues.
• 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 Local Study Manager (LSM) the correct timing and type of visits.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
• Follows quality issue processes by raising systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
• Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
• Ensures compliance with local, national and regional legislation, as applicable.

YOU SHOULD HAVE THE FOLLOWING QUALIFICATIONS AND SKILLS:

• It is preferred to have 2 years of experience as a CRA.
• Proficient Polish language level.
• Minimum M.Sc. or M. Art in related subject area, preferably in life science, or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of local regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. Experience in breast cancer TA will be additional advantage.
• 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.
• Perfect written and verbal communication skills.
• Perfect teamwork and interpersonal skills.
• Ability to travel nationally/internationally as the need arises.
• Experience in mentoring and coaching of CRAs

Please refer the Job description for details