Senior Clinical Research Associate

AstraZeneca

. Deliver studies at allocated sites as an active participant in local study teams .

Posted 11/2/2026full-timeUnited StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Study Management, including monitoring, data management, and compliance with ICH-GCP guidelines. Proven ability to drive site performance, manage recruitment, and collaborate effectively with cross-functional teams.

Highest-signal resume keywords

CRA Monitoring ExperienceICH-GCP Guidelines KnowledgeClinical Study ManagementRegulatory Submissions ExperienceExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementMonitoringData ManagementRecruitment PlanningSite SelectionInterim MonitoringCloseout VisitsKPI MonitoringETMF Quality ControlRegulatory Compliance

Soft Skills

Excellent Attention to DetailCollaboration SkillsNegotiation SkillsProactivityFlexibility

Tools & Technologies

CTMSETMFRemote Data ChecksE-Enabled Environment

Industry Keywords

Life Science DegreeGMPGDPDrug Development ProcessClinical TrialsMedical KnowledgeInvestigator NominationQuality Control ChecksAudit PreparationRegulatory Inspections

About the role

Key responsibilities & impact

Deliver studies at allocated sites as an active participant in local study teams
Collaborate with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistants, and other CRAs to achieve country-level study commitments
Act as the main contact with study sites and monitor study conduct for proper delivery and compliance
Select, initiate, monitor, and close assigned clinical-study sites
Perform selection, initiation, interim monitoring, and closeout visits, both remote and onsite, plus remote data checks
Drive site performance and resolve or escalate study-related issues
Train, support, and advise investigators and site staff, including on RBQM principles
Develop recruitment plans, manage enrollment, and document recruitment barriers and mitigation plans
Monitor study KPIs, including action-item aging, SDV, data-entry metrics, query aging, and monitoring-visit report metrics
Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators
Collect and upload essential documents to the eTMF and support regular eTMF quality-control checks
Support study start-up and regulatory maintenance, including EC/IRB and Regulatory Authority submissions where required
Contribute to investigator nomination, selection, and feasibility activities
Collaborate with Medical Affairs, MAP, and other internal stakeholders
Escalate systematic or serious quality issues, data privacy breaches, and ICH-GCP compliance issues
Prepare for and collaborate on audits and regulatory inspections

Requirements

What you’ll need

Minimum of 4 years of CRA monitoring experience
Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international ICH-GCP guidelines
Basic knowledge of GMP/GDP
Excellent knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas
Good understanding of the drug development process
Excellent understanding of Clinical Study Management, including monitoring, study drug handling and data management
Excellent attention to detail
Excellent written and verbal communication skills
Excellent collaboration and interpersonal skills
Good negotiation skills
Flexibility in schedule and willingness to travel, with required travel potentially as high as 70% during busy periods
Valid driving license
Ability to work with remote collaborators and in a matrix reporting structure
Ability to manage change positively
Ability to identify and champion efficient clinical-trial delivery methods
Ability to prioritize and manage multiple tasks with conflicting deadlines
Proactivity and assertiveness when communicating with internal stakeholders and sites
Ability to use and develop computer skills in an e-enabled environment
Team-oriented and flexible, with ability to respond quickly to shifting demands and opportunities
Experience in all study phases and rare medical conditions preferred

Benefits

Comp & perks

Inclusive environment with equal employment opportunities for all applicants and employees
Disability or special-needs accommodation available through the application form