Clinical Research Associate, Cell Therapy - Mid Atlantic

AstraZeneca

3d • $112,154 - $168,232

About The Position

The Clinical Research Associate (CRA) has local responsibility for delivering studies at allocated sites and participates in local study teams. Working closely with other CRAs and the Local Study Team and Local Study Associate Director (LSAD), the CRA helps ensure study commitments are achieved efficiently and on time. The CRA is the primary contact for study sites and monitors study conduct to support proper clinical-trial delivery.

This is a field-based position, with a strong preference for candidates residing in the Mid-Atlantic region, including Maryland, Virginia, Washington, D.C., Delaware, Pennsylvania, and New Jersey. The CRA prepares, initiates, monitors, and closes assigned sites in compliance with AstraZeneca procedural documents, ICH-GCP, and applicable local regulations. More experienced CRAs may take on additional responsibilities associated with the LSAD role.

Requirements

• Bachelor’s degree in Life Sciences or a related discipline, or equivalent qualification.
• At least 3 years of CRA or similar relevant clinical research experience in 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 and 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.
• Ability to work effectively 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

• Contribute to the selection of potential investigators.
• Support study start-up and regulatory maintenance, including Site Qualification Visits, regulatory document collection and review, and submissions to EC/IRB and Regulatory Authorities as applicable.
• Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles.
• Confirm site staff complete required training, including ICH-GCP training, and ensure sites remain inspection ready.
• Participate in Local Study Team meetings and contribute to Investigator Meetings as applicable.
• Initiate, monitor, and close study sites in compliance with AstraZeneca procedural documents; share patient recruitment and site performance updates with the Local Study Team.
• Drive site performance by identifying, resolving, and escalating study-related issues as appropriate.
• Update CTMS and other clinical systems within required timelines.
• Manage study supplies, Investigator Site File documentation, investigational product accountability, and study drug reconciliation or destruction where applicable.
• Perform onsite and remote monitoring visits, including remote data review, in accordance with study-specific Monitoring Plans.
• Perform Source Data Review, Source Data Verification, and CRF review activities.
• Conduct Site Quality Risk Assessments and adjust monitoring intensity throughout the study.
• Ensure timely resolution of data queries and collaborate with Data Management to maintain high-quality study data.
• Ensure timely and accurate reporting of Serious Adverse Events and follow-up documentation.
• Prepare and finalize monitoring visit reports and follow-up letters within required timelines and in accordance with AstraZeneca SOPs.
• Follow up on outstanding site actions to ensure timely resolution.
• Escalate significant quality issues, compliance concerns, data privacy breaches, or ICH-GCP deviations to Local Management and/or Quality teams as required.
• Help sites maintain inspection-ready Investigator Site Files and support audit and regulatory inspection readiness with LSAD and Quality teams.
• Ensure timely collection and upload of essential documents into the eTMF, and ensure study documentation is complete and ready for final archiving.
• Provide insights about investigators, sites, and competing studies relevant to the local market.
• Comply with AstraZeneca’s Code of Ethics, company policies, and applicable local, national, and regional regulations.
• Collaborate with local Medical Science Liaisons as directed by the LSAD or line management.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in the equity-based long-term incentive program for salaried roles.
• Eligibility to receive a retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.

What This Job Offers

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