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Clinical Research Associate - Delhi

0-2 years
Not Disclosed
10 Nov. 7, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Research Associate (CRA)

Location: India – Delhi
Job ID: R-238617
Job Type: Full-time
Work Mode: On-site / Hybrid (as applicable)
Posted Date: November 5, 2025
Application Deadline: November 14, 2025


About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company committed to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases.
At AstraZeneca, we’re more than a leading pharmaceutical company — we’re a place where innovation, collaboration, and lifelong learning thrive.


Key Responsibilities

Study Preparation & Start-Up

  • Participate in the selection of potential investigators.

  • Conduct Site Qualification Visits and manage documentation for EC/IRB and Regulatory Authority submissions.

  • Support study start-up activities and ensure compliance with regulatory and company requirements.

Site Management & Monitoring

  • Train and advise Investigators and site staff on study-related procedures, including Risk-Based Quality Management (RbQM) principles.

  • Verify that site personnel have completed required ICH-GCP and study-specific training.

  • Ensure continuous inspection readiness of all sites.

  • Conduct initiation, monitoring (onsite/remote), and close-out visits as per the Monitoring Plan.

  • Perform Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV).

  • Maintain accurate and timely updates in CTMS and ensure quality data entry.

Quality & Compliance

  • Conduct Site Quality Risk Assessments and adjust monitoring frequency as necessary.

  • Ensure timely resolution of data queries and accurate reporting of Serious Adverse Events (SAEs).

  • Support audit and inspection readiness in collaboration with LSAD and CQAD teams.

  • Ensure essential study documents are uploaded to eTMF in compliance with ICH-GCP and AstraZeneca SOPs.

  • Escalate quality or compliance issues following company procedures.

Operational Support

  • Manage investigational product supplies and accountability at the study site.

  • Prepare study drugs for destruction when applicable.

  • Participate in Local Study Team (LST) meetings and contribute to National Investigator Meetings.

  • Provide timely feedback to investigators and document all visit reports accurately.

Cross-functional Collaboration

  • Work closely with Data Management, Medical Science Liaisons (MSLs), and other internal teams to ensure robust data quality.

  • Contribute insights about investigators, sites, or competing studies for strategic planning.


Qualifications & Skills

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related fields.

  • In-depth knowledge of ICH-GCP, clinical trial processes, and regulatory guidelines.

  • Strong communication, analytical, and problem-solving skills.

  • Proficiency in clinical trial systems (CTMS, eTMF, EDC).

  • Ability to manage multiple sites and ensure compliance under pressure.


Why Join AstraZeneca?

  • Opportunity to work in a science-driven, innovative environment.

  • Collaborative culture that values diversity and inclusion.

  • Commitment to professional growth, training, and career advancement.

  • Meaningful work contributing to improving patient lives globally.


Application Information

Date Posted: November 5, 2025
Closing Date: November 14, 2025
Time Left to Apply: 7 days

Apply Now: AstraZeneca Careers


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Equal Opportunity Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive, diverse workforce representing all backgrounds and perspectives.
All qualified applicants will be considered without regard to gender, race, age, disability, religion, or any other protected status.

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