Clinical Research Associate, Cell Therapy - Mid Atlantic

The Clinical Research Associate (CRA) has local responsibility for the delivery of studies atallocatedsites 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 ina timelyand efficient manner. The CRA acts as the primary contact with study sites andis responsible for monitoring study conduct to ensure proper delivery of clinical trials.

This is a field-based position with a strong preference for candidates residing within the Mid-Atlantic region, including Maryland, Virginia, Washington D.C., Delaware, Pennsylvania, and New Jersey.

The CRAis responsible forthe 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 onadditionalresponsibilities, including tasks associated with the Local Study Associate Director (LSAD) role.

• Contributes to theselectionof 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 sitesremain inspection ready at all times.
• Activelyparticipatesin Local Study Team (LST) meetings.
• Contributes to Investigator Meetings as applicable.
• Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents.
  
  Sharesupdates 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 withstudy-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.
• Ensurestimelyresolution of data queries and collaborates with Data Management tomaintainhigh-quality study data.
• Ensuresaccurateandtimelyreporting of Serious Adverse Events (SAEs) and follow-up documentation.
• Prepares andfinalizesmonitoring visit reports and follow-up letters within required timelines andin accordance with
  
  AstraZeneca SOPs.
• Followsup on outstanding site actions to ensuretimelyresolution.
• Escalates significant quality issues, compliance concerns, data privacy breaches, or ICH-GCP deviations to Local Management and/or Quality teams as required.
• Assistssites inmaintaininginspection-ready Investigator Site Files (ISF).
• Supports audit and regulatoryinspectionreadiness activities in collaboration with LSAD and Quality teams.
• Ensurestimelycollection 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 insightsregardinginvestigators, 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 peoplepractices.
• Ensures compliance with local, national, and regional regulations as applicable.
• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line management.

• Bachelor’s degree in Life Sciences or related discipline, or equivalent qualification.
• Minimum3 yearsofCRAorsimilarrelevant 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…