Clinical Research Associate – Cell Therapy

AstraZeneca

3d • Remote

About The Position

The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the primary contact with study sites and is responsible for monitoring study conduct to ensure proper delivery of clinical trials. This is a field-based position with a strong preference for candidates based in Tennessee. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies in compliance with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations, ensuring that sites deliver according to study commitments. A CRA with longer tenure and experience may take on additional responsibilities, including tasks associated with the Local Study Associate Director (LSAD) role.

Requirements

• Bachelor’s degree in Life Sciences or related discipline, or equivalent qualification.
• Minimum 3 years of CRA or similar relevant clinical research experience within the pharmaceutical, biotechnology, or CRO industry.
• Excellent knowledge of ICH-GCP guidelines and basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations and clinical trial requirements.
• Strong medical and scientific aptitude with the ability to learn AstraZeneca therapeutic areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management, including site monitoring, study drug handling, and data management.
• Strong attention to detail and documentation accuracy.
• Excellent written and verbal communication skills.
• Strong collaboration, interpersonal, and relationship-building skills.
• Good negotiation and conflict-resolution skills.
• Ability to travel nationally and internationally as required.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level