AstraZeneca
Pharmaceuticals
SeniorClinicalResearchAssociate
“Senior Clinical Research Associate at AstraZeneca. Skills: Clinical Study Management, monitoring, ICH-GCP. Deliver studies at allocated sites. Monitor study conduct”
What You'll Achieve.
ensure study commitments are achieved; ensure proper delivery of the study; sites deliver according to their respective commitment; ensure sites are inspection ready at all times; ensure timely resolution to study-related issues; ensure robust quality of the collected study data; ensure accurate and timely reporting of Serious Adverse Events; ensure resolution in a timely manner; ensure timely collection/uploading of essential documents
Industry & Context.
Proactively identifies and ensures timely resolution to study-related issues
monitoring visits (remote and onsite)
What They're Looking For.
Must Have
Bachelor degree in related discipline, preferably in life science, or equivalent qualification, Excellent knowledge of international guidelines ICH-GCP, Good knowledge of relevant local regulations, Good medical knowledge, Ability to learn relevant AZ Therapeutic Areas, Basic understanding of the drug development process, Good understanding of Clinical Study Management including monitoring, study drug handling and data management, Excellent attention to details, Good written and verbal communication skills, Good collaboration and interpersonal skills, Good negotiation skills
Nice to Have
basic knowledge of GMP/GDP
What You'll Do.
Deliver studies at allocated sites
Monitor study conduct
Ensure compliance with guidelines
Participate in Local Study Team meetings
and close study sites
Share site progress information
Drive performance at sites
Resolve study-related issues
Update CTMS and other systems
Manage study supplies
Perform monitoring visits
Perform Source Data Review
Perform Site Quality Risk Assessments
Ensure data query resolution
Ensure accurate reporting of Serious Adverse Events
Prepare monitoring visit reports
Follow up on outstanding actions
Follow quality issue processes
Assist site in maintaining inspection ready ISF
Collaborate with audits and inspections
Ensure timely collection/uploading of essential documents
Provide feedback on research related information
Ensure compliance with AstraZeneca’s Code of Ethics
Ensure compliance with company policies
Ensure compliance with SHE
Ensure compliance with legislation
How You'll Work.
Team & Collaboration
Works in close collaboration with other CRAs; Active participant in local study team(s); Actively participates in Local Study Team (LST) meetings; Shares information within the LST; Collaborates with local MSLs
Communication Scope
Good written and verbal communication skills
Process & Methodology
Clinical Study Management
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