Remote Cell Therapy CRA (MI/OH)

AstraZeneca plc; Lansing (MI); Remote; USD 112,000 - 168,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation and holidays

Paid leaves

Health benefits

Job summary

AstraZeneca plc is seeking a Clinical Research Associate (CRA) to oversee study delivery at allocated sites in the Michigan/Ohio region. The role emphasizes monitoring, regulatory compliance, and collaboration with Local Study Teams to meet study commitments.

Requirements include a life-science degree and 3+ years CRA experience, strong knowledge of ICH-GCP, and the ability to travel nationally/internationally. Remote work within the Michigan/Ohio area is accepted.

Qualifications

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• 3+ years experience as a CRA.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license

Responsibilities

• Contributes to the selection of potential investigators.
• Trains, supports and advises Investigators and site staff in study related matters.
• Performs monitoring visits (remote and onsite) and remote data checks as per Monitoring Plan.
• Updates CTMS and other systems with data from study sites.
• Manages study supplies and drug accountability at study site.
• Prepares for and collaborates with audits and regulatory inspections.
• Ensures compliance with AZ SOPs and ICH-GCP requirements.
• Provides feedback on site performance and quality issues.

Skills

Communication skills

Attention to detail

Negotiation skills

Team collaboration

Verbal communication

Education

Bachelor degree in life science or related discipline

Job description

AstraZeneca plc is seeking a Clinical Research Associate (CRA) to oversee study delivery at allocated sites in the Michigan/Ohio region. The role emphasizes monitoring, regulatory compliance, and collaboration with Local Study Teams to meet study commitments.

Requirements include a life-science degree and 3+ years CRA experience, strong knowledge of ICH-GCP, and the ability to travel nationally/internationally. Remote work within the Michigan/Ohio area is accepted.