AstraZeneca
Pharmaceuticals
ClinicalResearchAssociate-12MonthContract
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Associate - 12 Month Contract at AstraZeneca. Skills: Clinical Study Management, ICH-GCP, Monitoring, Data Management. Deliver studies at allocated sites. Monitor study conduct”
What You'll Achieve.
Ensure study commitments are achieved in a timely and efficient manner; Ensure proper delivery of study conduct; Drives performance at the sites; Ensures timely resolution to study-related issues; Ensures timely data query resolution; Ensures robust quality of the collected study data; Ensures accurate and timely reporting of Serious Adverse Events; Ensures timely feedback to the Principal Investigator; Ensures timely resolution of outstanding actions; Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures; Ensures compliance with local, national and regional legislation
Industry & Context.
Proactively identifies and ensures timely resolution to study-related issues; Escalates them as appropriate; Good analytical and problem-solving skills
Ability to travel nationally/internationally as required, Valid G driving license
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, basic knowledge of GMP/GDP, 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, Ability to travel nationally/internationally as required, Valid G driving license
Nice to Have
Ability to work in an environment of remote collaborators, Manages change with a positive approach for self, team and the business, Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time, Good analytical and problem-solving skills, Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines, Familiar with risk-based monitoring approach including remote monitoring, Good cultural awareness, Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment, Team oriented and ability to respond quickly to shifting demands and opportunities
What You'll Do.
Deliver studies at allocated sites
Monitor study conduct
and advise Investigators
Confirm site staff training
Ensure sites are inspection ready
Participate in Local Study Team meetings
Contribute to National Investigators meetings
Drive performance at sites
Resolve study-related issues
Update CTMS and other systems
Manage study supplies
Perform monitoring visits
Perform Source Data Review
Perform Source Data Verification
Perform Site Quality Risk Assessments
Ensure data query resolution
Ensure accurate reporting of Serious Adverse Events
Prepare and finalize monitoring visit reports
Follow up on outstanding actions
Escalate quality issues
Assist site in maintaining inspection-ready ISF
Collaborate with audits and inspections
Ensure timely collection/uploading of essential documents
Support/participate in regular QC checks
Ensure study documents are ready for archiving
Provide feedback on research-related information
Ensure compliance with Code of Ethics
Ensure compliance with company policies
Ensure compliance with local legislation
How You'll Work.
Team & Collaboration
Active participant in the local study team(s); Works closely with other CRAs; Works closely with the Local Study Team/Local Study Associate Director (LSAD); 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; Good collaboration and interpersonal skills; Good negotiation skills
Process & Methodology
Manage multiple tasks with conflicting deadlines
Full Job Description
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. ## Introduction to role The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s). The CRA works closely with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. Acting as the main contact with the study site, the CRA is responsible for monitoring the study conduct to ensure proper delivery. The CRA prepares, initiates, monitors, and closes assigned sites in clinical studies, following AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. A CRA with longer tenure and experience may take on additional responsibilities associated with LSAD. ## Accountabilities * Contributes to the selection of potential investigators. * In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. * Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles. *
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