Clinical Research Associate, Cell Therapy
Healthcare
ClinicalResearchAssociate,CellTherapy
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Associate, Cell Therapy at Clinical Research Associate, Cell Therapy. Skills: Clinical trial management, Site monitoring, Regulatory compliance, ICH-GCP guidelines. Contribute to investigator selection. Support study start-up”
Industry & Context.
Issue resolution; Conflict resolution; Problem-solving capabilities
Field-based position, Travel nationally, Travel internationally
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, Minimum 3 years CRA experience, Excellent knowledge of ICH-GCP, Basic knowledge of GMP/GDP, Good knowledge of local regulations, Medical and scientific aptitude, Basic understanding of drug development, Good understanding of Clinical Study Management, Attention to detail, Documentation accuracy, Excellent written communication skills, Excellent verbal communication skills, Interpersonal skills, Relationship-building skills, Good negotiation skills, Conflict-resolution skills, Ability to travel nationally, Ability to travel internationally
Nice to Have
Clinical trial experience in Cell Therapy, Experience in Cell Therapy, Ability to work effectively remotely, Ability to work with cross-functional teams, Positive approach to change management, Adaptable approach to change management, Ability to identify process improvements, Ability to champion process improvements, Analytical capabilities, Problem-solving capabilities, Ability to prioritize effectively, Manage multiple competing deadlines, Familiarity with risk-based monitoring, Familiarity with remote monitoring, Good cultural awareness, Ability to work within global teams, Proficiency with clinical systems, Proficiency with software platforms, Proficiency with technology-enabled environments, Team-oriented, Flexible, Responsive to shifting priorities, Responsive to business needs
What You'll Do.
Contribute to investigator selection
Support study start-up
Support regulatory maintenance
Collect and review regulatory documents
Submit to Regulatory Authorities
Support investigators
Confirm site staff training completion
Ensure sites remain inspection ready
Participate in Local Study Team meetings
Contribute to Investigator Meetings
Share patient recruitment updates
Share site performance updates
Drive site performance
Identify study-related issues
Resolve study-related issues
Escalate study-related issues
Update clinical systems
Manage study supplies
Manage ISF documentation
Manage investigational product accountability
Manage study drug reconciliation
Manage study drug destruction
Perform onsite monitoring visits
Perform remote monitoring visits
Perform remote data review
Perform Source Data Review
Perform Source Data Verification
Conduct Site Quality Risk Assessments
Adjust monitoring intensity
Ensure timely resolution of data queries
Collaborate with Data Management
Maintain high-quality study data
Ensure accurate SAE reporting
Ensure timely SAE reporting
Ensure timely reporting of follow-up documentation
Prepare monitoring visit reports
Finalize monitoring visit reports
Prepare follow-up letters
Finalize follow-up letters
Follow up on outstanding site actions
Ensure timely resolution of site actions
Escalate significant quality issues
Escalate compliance concerns
Escalate data privacy breaches
Escalate ICH-GCP deviations
Assist sites in maintaining ISF
Support audit readiness activities
Support regulatory inspection readiness
Ensure timely collection of essential documents
Ensure timely upload of essential documents
Ensure compliance with ICH-GCP
Ensure compliance with AstraZeneca SOPs
Ensure compliance with local requirements
Ensure study documentation completeness
Prepare study documentation for archiving
Provide insights regarding investigators
Provide insights regarding sites
Provide insights regarding competing studies
Ensure compliance with AstraZeneca’s Code of Ethics
Ensure compliance with company policies
Ensure compliance with SHE policies
Ensure compliance with security policies
Ensure compliance with technology policies
Ensure compliance with finance policies
Ensure compliance with people practices policies
Ensure compliance with local regulations
Ensure compliance with national regulations
Ensure compliance with regional regulations
Collaborate with local MSLs
How You'll Work.
Team & Collaboration
Local Study Team; Cross-functional teams; Global teams
Communication Scope
Written communication; Verbal communication
Process & Methodology
Clinical Study Management
Full Job Description
The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the primary contact with study sites and is responsible for monitoring study conduct to ensure proper delivery of clinical trials. **This is a field-based position with a strong preference for candidates based in Texas.** The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies in compliance with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations, ensuring that sites deliver according to study commitments. A CRA with longer tenure and experience may take on additional responsibilities, including tasks associated with the Local Study Associate Director (LSAD) role. **Typical Accountabilities** * Contributes to the selection of potential investigators. * Supports study start-up and regulatory maintenance activities, including Site Qualification Visits (SQVs), collection and review of regulatory documents, and submission activities to EC/IRB and Regulatory Authorities as applicable. * Trains, supports, and advises investigators and site staff on study-related matters, including Risk Based Quality Management (RbQM) principles. * Confirms site staff have completed required training, including ICH-GCP training, prior to and throughout the study duration. Ensures sites remain inspection ready at all times. * Actively participates in Local Study Team (LST) meetings. * Contributes to Investigator Meetings as applicable. * Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents. Shares updates on patient recruitment and site performance within the LS
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