Clinical Research Associate, Cell Therapy

Typical Accountabilities

• Contributes to the selection of potential investigators.  

• Supports study start-up and regulatory maintenance activities, including Site Qualification Visits (SQVs), collection and review of regulatory documents, and submission activities to EC/IRB and Regulatory Authorities as applicable.  

• Trains, supports, and advises investigators and site staff on study-related matters, including Risk Based Quality Management (RbQM) principles.  

• Confirms site staff have completed required training, including ICH-GCP training, prior to and throughout the study duration. Ensures sites remain inspection ready at all times.  

• Actively participates in Local Study Team (LST) meetings.  

• Contributes to Investigator Meetings as applicable.  

• Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents. Shares updates on patient recruitment and site performance within the LST.  

• Drives site performance by proactively identifying, resolving, and escalating study-related issues as appropriate.  

• Updates CTMS and other clinical systems within required timelines.  

• Manages study supplies, ISF documentation, investigational product accountability, and study drug reconciliation/destruction activities where applicable.  

• Performs onsite and remote monitoring visits, including remote data review activities, in accordance with study-specific Monitoring Plans.  

• Performs Source Data Review (SDR), Source Data Verification (SDV), and CRF review activities.  

• Conducts Site Quality Risk Assessments and adjusts monitoring intensity accordingly throughout the study.  

• Ensures timely resolution of data queries and collaborates with Data Management to maintain high-quality study data.  

• Ensures accurate and timely reporting of Serious Adverse Events (SAEs) and follow-up documentation.  

• Prepares and finalizes monitoring visit reports and follow-up letters within required timelines and in accordance with AstraZeneca SOPs.  

• Follows up on outstanding site actions to ensure timely resolution.  

• Escalates significant quality issues, compliance concerns, data privacy breaches, or ICH-GCP deviations to Local Management and/or Quality teams as required.  

• Assists sites in maintaining inspection-ready Investigator Site Files (ISF).  

• Supports audit and regulatory inspection readiness activities in collaboration with LSAD and Quality teams.  

• Ensures timely collection and upload of essential documents into the eTMF in compliance with ICH-GCP, AstraZeneca SOPs, and local requirements.  

• Ensures study documentation is complete and ready for final archiving activities.  

• Provides insights regarding investigators, sites, and competing studies relevant to the local market.  

• Ensures compliance with AstraZeneca’s Code of Ethics and company policies related to Safety, Health & Environment (SHE), security, technology, finance, and people practices.  

• Ensures compliance with local, national, and regional regulations as applicable.  

• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line management.  

Desirable Qualifications

• Clinical trial or relevant experience in Cell Therapy preferred. Ability to work effectively in an environment with remote collaborators and cross-functional teams.  

• Positive and adaptable approach to change management.  

• Ability to identify and champion process improvements that increase efficiency and quality.  

• Strong analytical and problem-solving capabilities.  

• Ability to prioritize and manage multiple competing deadlines effectively.  

• Familiarity with risk-based monitoring methodologies, including remote monitoring.  

• Good cultural awareness and ability to work within global teams.  

• Proficiency with clinical systems, software platforms, and technology-enabled environments.  

• Team-oriented, flexible, and responsive to shifting priorities and business needs. 

• 401(k) plan

• Paid vacation and holidays

• Paid leaves

• Medical, prescription drug, dental and vision coverage

• Short-term incentive bonus

• Equity-based long-term incentive program