Field CRA – Mid-Atlantic Travel & Site Monitoring

AstraZeneca plc; Wilmington (DE); On-site; USD 112,000 - 168,000; Full time

Job summary

AstraZeneca plc is seeking a Clinical Research Associate (CRA) to oversee clinical study delivery at allocated sites in the Mid-Atlantic region. The role collaborates with Local Study Teams to ensure timely commitments, conducts on-site and remote monitoring, and maintains inspection readiness.

Travel nationally and internationally is required. The candidate should have a life sciences degree and 3+ years in CRA or similar clinical research, with strong ICH-GCP knowledge and excellent

Qualifications

• Bachelor's degree in Life Sciences or related discipline, or equivalent qualification.
• Minimum 3 years of CRA or similar clinical research experience.
• 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.

Responsibilities

• Contributes to the selection of potential investigators.
• Supports study start-up and regulatory maintenance activities, including SQVs, regulatory document review, and submissions to EC/IRB and authorities.
• Trains, supports, and advises investigators and site staff on study-related matters.
• Ensures sites remain inspection ready and training completed.
• Participates in Local Study Team meetings and Investigator Meetings as applicable.
• Initiates, monitors, and closes study sites in compliance with AstraZeneca SOPs.
• Drives site performance by identifying and escalating study-related issues.
• Updates CTMS and other clinical systems within required timelines.
• Manages study supplies, ISF documentation, and study drug reconciliation/destruction where applicable.
• Performs onsite and remote monitoring visits, including remote data review.
• Performs SDR, SDV, and CRF review activities.
• Conducts Site Quality Risk Assessments and adjusts monitoring intensity.
• Ensures timely resolution of data queries and quality data reporting.
• Escalates significant issues to management and quality teams.
• Supports audit and regulatory inspection readiness activities with LSAD and Quality teams.
• Ensures timely collection and upload of essential documents into eTMF.
• Ensures study documentation is complete and ready for final archiving.

Skills

ICH-GCP

GMP/GDP

Communication

Travel willingness

Team collaboration

Negotiation skills

Education

Bachelor’s degree in Life Sciences or related discipline

Job description

AstraZeneca plc is seeking a Clinical Research Associate (CRA) to oversee clinical study delivery at allocated sites in the Mid-Atlantic region. The role collaborates with Local Study Teams to ensure timely commitments, conducts on-site and remote monitoring, and maintains inspection readiness.

Travel nationally and internationally is required. The candidate should have a life sciences degree and 3+ years in CRA or similar clinical research, with strong ICH-GCP knowledge and excellent