Senior Clinical Research Associate

AstraZeneca

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

Posted 11/12/2026full-timeUnited StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Study Management, including ICH-GCP compliance, monitoring, and data management, while effectively collaborating with cross-functional teams and managing study site performance. Possesses strong communication and negotiation skills to support investigator training and recruitment strategies.

Highest-signal resume keywords

CRA Monitoring ExperienceICH-GCP Guidelines KnowledgeClinical Study ManagementExcellent Written And Verbal Communication SkillsAbility To Manage Multiple Tasks

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementMonitoringData ManagementRecruitment PlanningRegulatory ComplianceRisk Based Quality ManagementKPI MonitoringETMF Quality ControlStudy Site SelectionDrug Development Process

Soft Skills

Excellent Collaboration SkillsInterpersonal SkillsNegotiation SkillsProactivityFlexibility

Tools & Technologies

CTMSETMF

Industry Keywords

Life ScienceGMPGDPClinical TrialsRegulatory AuthoritiesEC/IRBMedical KnowledgeRare Medical Conditions

About the role

Key responsibilities & impact

Deliver clinical studies at allocated sites as an active participant in local study teams
Collaborate with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistant, and other Country Operations Management staff
Act as the primary contact for study sites and monitor study conduct for proper delivery and compliance
Select, initiate, monitor, and close assigned clinical-study sites in compliance with Alexion procedures, ICH-GCP, and local regulations
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 Risk Based Quality Management principles
Develop recruitment plans, support enrollment, and document recruitment barriers and mitigation plans
Monitor study KPIs, including action-item aging, SDV, data-entry, query-aging, and monitoring-visit-report metrics
Prepare and finalize monitoring visit reports in CTMS and provide timely feedback and follow-up letters 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 preparing, submitting, and tracking documents for EC/IRB and Regulatory Authorities where required
Contribute to investigator nomination and selection and assist with feasibility activities
Collaborate with Medical Affairs, Medical Advisor Pipeline, 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; required travel may be 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 and effective 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 understand technology’s impact on projects and use/develop computer skills in an e-enabled environment
Team-oriented and flexible; 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 process