Field Clinical Research Associate - Mid-Atlantic

AstraZeneca plc; United States; Remote; USD 112,000 - 168,000; Full time

Job summary

AstraZeneca plc is seeking a field-based Clinical Research Associate (CRA) to deliver study activities at allocated sites across the United States. The CRA will collaborate with Local Study Teams and LSAD, ensuring timely delivery of study commitments with a focus on site monitoring and data quality.

The role requires travel nationally and internationally as needed, with preference for candidates in the Mid-Atlantic region.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline, or equivalent qualification.
• Minimum 3 years CRA or similar clinical research experience.
• Excellent knowledge of ICH-GCP guidelines and basic 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 site selection and investigator engagement.
• Supports start-up and regulatory maintenance activities (SQVs, regulatory document reviews).
• Trains and advises investigators and site staff on study-related matters.
• Ensures training compliance and inspection readiness of sites.
• Participates in Local Study Team meetings and Investigator Meetings.
• Initiates, monitors, and closes study sites in line with SOPs.
• Escalates quality and regulatory issues to management and Quality teams.
• Maintains ISF and eTMF documentation in compliance with ICH-GCP and SOPs.
• Ensures timely reporting of SAEs and follow-up documentation.
• Collaborates with Data Management to maintain high-quality study data.

Skills

Attention to detail

Effective communication

Travel readiness

Site monitoring familiarity

Risk-based quality management

Education

Bachelor’s degree in Life Sciences or related discipline

Minimum 3 years CRA or similar clinical research experience

Tools

Clinical systems proficiency

Job description

AstraZeneca plc is seeking a field-based Clinical Research Associate (CRA) to deliver study activities at allocated sites across the United States. The CRA will collaborate with Local Study Teams and LSAD, ensuring timely delivery of study commitments with a focus on site monitoring and data quality.

The role requires travel nationally and internationally as needed, with preference for candidates in the Mid-Atlantic region.