Job Title: Clinical Research Associate
Location: Karnataka, India
Industry: Pharma / Healthcare / Clinical Research
Job ID: R-229938
Application Deadline: July 31, 2025
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company committed to transforming the lives of patients through innovative medicines. With a strong presence in over 100 countries, AstraZeneca focuses on oncology, cardiovascular, renal & metabolism, and respiratory diseases. The company not only delivers life-changing medicines but also contributes significantly to the economy by investing in jobs, research, and healthcare advancements.
In 2009, AstraZeneca commissioned an independent report by Oxera, an economic consultancy, highlighting its substantial contributions to the UK economy, including job creation and healthcare innovation. This commitment extends globally, making AstraZeneca a preferred employer for professionals in the pharmaceutical and clinical research sectors.
Job Description: Clinical Research Associate (CRA)
As a Clinical Research Associate (CRA) at AstraZeneca, you will play a crucial role in ensuring the smooth execution of clinical trials while maintaining compliance with regulatory standards.
Key Responsibilities:
✔ Contribute to investigator selection and study site feasibility assessments.
✔ Conduct Site Qualification Visits (SQV), initiation, monitoring, and close-out visits (both onsite and remote).
✔ Ensure regulatory document collection, submission, and maintenance for EC/IRB approvals.
✔ Train and support investigators and site staff on ICH-GCP guidelines, Risk-Based Quality Management (RbQM), and protocol adherence.
✔ Perform Source Data Verification (SDV), Case Report Form (CRF) reviews, and ensure timely data entry & query resolution.
✔ Monitor patient recruitment, site performance, and escalate issues as needed.
✔ Maintain Inspection-Ready Investigator Site Files (ISF) and ensure eTMF compliance.
✔ Collaborate with Local Study Teams (LST) and stakeholders for smooth study execution.
✔ Ensure timely reporting of Serious Adverse Events (SAEs) and follow-ups.
✔ Support audits, regulatory inspections, and implement innovative clinical trial processes.
Qualifications & Skills Required:
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Medicine, or related fields.
- Prior experience as a CRA or in clinical trial monitoring is preferred.
- Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial processes.
- Excellent communication, problem-solving, and organizational skills.
- Ability to travel to study sites as required.
How to Apply?
If you are passionate about clinical research and want to work with a global pharmaceutical leader, apply before July 31, 2025.