Senior Clinical Research Associate

AstraZeneca

. Deliver studies at allocated sites and participate in local study teams .

Posted 10/23/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Study Management, including ICH-GCP compliance, site monitoring, and regulatory submissions. Proficient in managing study KPIs and collaborating with cross-functional teams to ensure efficient clinical trial delivery.

Highest-signal resume keywords

CRA Monitoring ExperienceICH-GCP KnowledgeClinical Study ManagementRegulatory ComplianceExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementSite MonitoringData ManagementRecruitment PlanningKPI MonitoringRegulatory SubmissionsInterim MonitoringCloseout VisitsETMF Quality ControlGMP/GDP Knowledge

Soft Skills

Excellent Attention to DetailCollaboration SkillsNegotiation SkillsFlexibilityProactivity

Tools & Technologies

CTMSETMFRemote Collaboration Tools

Industry Keywords

Clinical TrialsDrug Development ProcessLife SciencesRegulatory AuthoritiesMedical Knowledge

About the role

Key responsibilities & impact

Deliver studies at allocated sites and participate in local study teams
Collaborate with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistant, and other Country Operations Management colleagues
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 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 RBQM principles
Develop recruitment plans, manage 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 document preparation, tracking, and submissions to EC/IRB and Regulatory Authorities where required
Contribute to investigator nomination and selection and assist with 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 guidelines ICH-GCP
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 and effective clinical-trial delivery methods and processes
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 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 and special-needs accommodation available through the application form