Clinical Research Associate, Cell Therapy - Mid Atlantic

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 residing within the Mid-Atlantic region, including Maryland, Virginia, Washington D.C., Delaware, Pennsylvania, and New Jersey. 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.   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 u