Remote CRA - Cell Therapy (MI/OH) — Growth & Equity

AstraZeneca plc; Ohio; Remote; USD 112.000 - 168.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Health benefits

Paid vacation and holidays

Zusammenfassung

AstraZeneca plc is seeking a Clinical Research Associate to support site selection, monitoring, and regulatory start-up across Michigan/Ohio. The role involves remote and on-site visits, data checks, and collaboration with Local Study Teams.

You will ensure ICH-GCP adherence, training of site staff, accurate documentation, and timely reporting of SAEs, while traveling nationally as needed and maintaining inspection readiness.

Qualifikationen

• Bachelor degree in life science or equivalent.
• 3+ years experience as a CRA.
• Excellent knowledge of ICH-GCP and GMP/GDP.
• Good knowledge of local regulations.
• Understanding of the drug development process.
• Experience in Clinical Study Management including monitoring and data management.

Aufgaben

• Contributes to investigator selection and site qualification.
• Performs monitoring visits (remote and onsite) and data checks.
• Manages study supplies and drug accountability at sites.
• Ensures data query resolution and collaboration with data management.
• Maintains inspection readiness and prepares monitoring reports.

Kenntnisse

Communication skills

Attention to detail

Collaboration

Negotiation skills

Travel ability

Driving license

Ausbildung

Bachelor degree in life sciences

Jobbeschreibung

AstraZeneca plc is seeking a Clinical Research Associate to support site selection, monitoring, and regulatory start-up across Michigan/Ohio. The role involves remote and on-site visits, data checks, and collaboration with Local Study Teams.

You will ensure ICH-GCP adherence, training of site staff, accurate documentation, and timely reporting of SAEs, while traveling nationally as needed and maintaining inspection readiness.