Senior Clinical Research Associate

AstraZeneca

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

Posted 11/7/2026full-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 and local regulations. Proven ability to drive site performance, manage recruitment plans, and collaborate effectively with cross-functional teams.

Highest-signal resume keywords

CRA Monitoring ExperienceICH-GCP KnowledgeClinical Study ManagementRegulatory ComplianceAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementMonitoringData ManagementRecruitment PlanningKPI MonitoringRisk Based Quality ManagementGMP KnowledgeGDP KnowledgeStudy Phase ExperienceMedical Knowledge

Soft Skills

Excellent Communication SkillsCollaboration SkillsNegotiation SkillsFlexibilityProactivity

Tools & Technologies

CTMSETMF

Industry Keywords

Clinical Research AssociateDrug Development ProcessRegulatory AuthoritiesEC/IRBQuality ControlAuditsInspectionsMatrix Reporting StructureRemote CollaborationRare Medical Conditions

About the role

Key responsibilities & impact

Deliver clinical 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
Perform selection, initiation, interim monitoring, closeout, remote data-check, remote, and onsite visits according to study timelines and the Clinical Monitoring Plan
Drive site performance and identify, resolve, and escalate study-related issues
Train, support, and advise Investigators and site staff, including on Risk Based Quality Management principles
Develop recruitment plans, manage and 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, reviewing, tracking, and submitting documents to 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 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
Experience in all study phases and in rare medical conditions preferred
Ability to work in an environment of remote collaborators and in a matrix reporting structure
Ability to prioritize and manage multiple tasks with conflicting deadlines
Proactivity and assertiveness when communicating with internal stakeholders and sites
Ability to understand the impact of technology on projects and use and develop computer skills in an e-enabled environment
Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities

Benefits

Comp & perks

Equal employment opportunities for all applicants and employees
Disability and special-needs accommodation available through the application form