Field-Based CRA — Cell Therapy Trials

Regulatory Jobs; United States; Remote; USD 112,000 - 168,000; Full time

Job summary

AstraZeneca is seeking a Clinical Research Associate (CRA) to carry local responsibility for study delivery at allocated sites and to actively participate in local study teams. This field-based role prefers candidates residing in the Mid-Atlantic region (MD, VA, DC, DE, PA, NJ).

The CRA will prepare, initiate, monitor, and close sites in compliance with ICH-GCP, AstraZeneca procedures, and local regulations, and may take on LSAD-related responsibilities with tenure.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• Minimum 3 years of CRA or similar clinical research experience.
• Excellent knowledge of ICH-GCP guidelines.
• Good knowledge of local regulations and trial requirements.
• Ability to travel nationally and internationally as required.

Responsibilities

• Delivery of studies at allocated sites and active participation in local study teams.
• Prepare, initiate, monitor, and close sites per SOPs and regulatory requirements.
• Train and advise investigators and site staff on study-related matters.
• Update CTMS and maintain study documentation for inspections.
• Ensure timely reporting of SAEs and follow-up documentation.
• Perform onsite and remote monitoring visits and data review.
• Collaborate with LSAD, LST, and regulatory authorities as applicable.
• Maintain ISF and source data review/verification activities.

Skills

Field monitoring

ICH-GCP

Regulatory knowledge

Site coordination

Data management

Education

Bachelor’s degree in Life Sciences

Job description

AstraZeneca is seeking a Clinical Research Associate (CRA) to carry local responsibility for study delivery at allocated sites and to actively participate in local study teams. This field-based role prefers candidates residing in the Mid-Atlantic region (MD, VA, DC, DE, PA, NJ).

The CRA will prepare, initiate, monitor, and close sites in compliance with ICH-GCP, AstraZeneca procedures, and local regulations, and may take on LSAD-related responsibilities with tenure.