AstraZeneca
Pharmaceuticals
ClinicalResearchAssociateCAR-T
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Associate CAR-T at AstraZeneca. Skills: Clinical Research Associate (CRA), CAR-T Cell Therapy studies, ICH-GCP, Monitoring, Site management. Delivery of CAR-T Cell Therapy studies at allocated sites. Monitoring study conduct”
What You'll Achieve.
Ensure study commitments are achieved in a timely and efficient manner; Ensure proper delivery of the study; Ensure sites deliver according to their respective commitment in the individual studies; Drive performance at the sites; Ensure timely resolution to study-related issues; Ensure data query resolution in a timely manner; Ensure accurate and timely reporting of Serious Adverse Events and their follow ups; Ensure sites are ready for inspection at all times
Industry & Context.
Good negotiation and problem solving skills; Proactively identifies and ensures timely resolution to study-related issues
Ability to travel nationally/internationally as required, Valid driving license
What They're Looking For.
Must Have
Scientific Degree equivalent degree, Experience on management of CAR-T Cell Therapy studies, 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, Good collaboration and interpersonal skills, Good negotiation and problem solving skills, Ability to travel nationally/internationally as required, Valid driving license
Nice to Have
Demonstrated project management skills including scope, budget, timeline, resource management and use of associated tools, Experience from Clinical Research/Operations (i e hands on work with Clinical Trial Management in the pharmaceutical industry), Knowledge of R&D ways of working, Ability to effectively work with External Service Providers, Ability to look for and champion more efficient and effective methods/processes
What You'll Do.
Delivery of CAR-T Cell Therapy studies at allocated sites
Monitoring study conduct
monitoring and closure of assigned sites
support and advice to Investigators and site staff
Site performance management
Issue resolution and escalation
Study supplies and drug management
Performing monitoring visits
Source Data Review (SDR)
Case Report Form (CRF) review and Source Data Verification (SDV)
Site Quality Risk Assessments
Data query resolution
Serious Adverse Events reporting
Monitoring visit report finalization
Quality issue escalation
Assisting site in maintaining inspection ready ISF
Collaboration with audits and regulatory inspections
Ensuring timely collection/uploading of essential documents
Ensuring study documents are ready for final archiving
Collaboration with local MSLs
Management of activities and account relationships according to Company Values
Guidelines/Internal procedures relating to people
security and SHE (Safety
Health and Environment) and local
national and regional legislation
How You'll Work.
Team & Collaboration
Work in close collaboration with other CRAs; Work with the Local Study Team/ Local Study Associate Director; Act as the main contact with the study site; Actively participates in Local Study Team (LST) meetings; Contributes to National Investigators meetings; Shares information on patient recruitment and study site progress within the LST; Collaborates with local MSLs as directed by LSM or line manager; Collaborates with LSM and CQM for audits and regulatory inspections
Communication Scope
Good written and verbal communication skills
Process & Methodology
Demonstrated project management skills including scope, budget, timeline, resource management and use of associated tools
Full Job Description
**Clinical Research Associate CAR-T** At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a**Clinical Research Associate (CRA)** in Italy, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. The future of treatment for many of today’s diseases lies in uncovering mechanisms that are newly emerging or are still to be discovered. We believe the best way to help patients is to focus on breakthrough science to discover these mechanisms and develop novel, targeted therapies that interact with them. As **Clinical Research Associate (CRA)** you will have local responsibility for the delivery of **the CAR-T Cell Therapy** studies at allocated sites and is an active participant in the local study teams. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us. **MAIN DUTIES AND RESPONSIBILITIES** As CRA you will work in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director 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. The role broadly includes the following key components: * Contributes to the selection of potential investigators. * Performs Site Qualification Visits, collection, preparation, review and
Applying for this Clinical Research Associate CAR-T role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about AstraZeneca?
Real rants from real employees. Read before you apply.