AstraZeneca is looking for a Clinical Research Associate to ensure the successful delivery of clinical studies at allocated sites, collaborating with study teams to meet commitments efficiently and on time. The role involves monitoring study conduct, ensuring compliance with guidelines and regulations, and driving performance at sites to advance cancer treatment.
Requirements
- 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.
- Familiarity with risk-based monitoring approach including remote monitoring.
- Understanding of technology's impact on projects; adept at using systems/software in an e-enabled environment.
Responsibilities
- Initiate, monitor, and close study sites in compliance with AZ Procedural Documents.
- Perform monitoring visits and data checks according to the Monitoring Plan.
- Conduct Source Data Review, Case Report Form review, and Source Data Verification.
- Ensure timely data query resolution and robust quality of collected study data.
- Report Serious Adverse Events accurately and promptly.
- Prepare monitoring visit reports and follow up on outstanding actions.
- Ensure timely collection/uploading of essential documents into the eTMF.
Other
- Collaborate closely with fellow CRAs and Local Study Managers to meet study commitments efficiently and on time.
- Train and support Investigators and site staff in study-related matters.
- Ensure site staff complete required trainings and maintain inspection readiness.
- Participate actively in Local Study Team meetings and National Investigators meetings.
- Ability to travel nationally/internationally as required.
