Clinical Research Associate

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Short Role Description

The Clinical Research Associate (CRA) has local responsibility for delivery of studies at assigned sites and actively participates as a member of the local study team. Working in close collaboration with other CRAs and the Local Study Team or Local Study Associate Director (LSAD), the CRA ensures that study commitments are met efficiently and within required timelines.

The CRA role is the primary contact for the study site and has the responsibility for monitoring study conduct and ensuring proper study delivery. The role encompasses the preparation, initiation, monitoring, and closure of allocated clinical study sites, in accordance with AstraZeneca’s procedural documents, international guidelines such as ICH-GCP, and relevant local regulations, ensuring each site delivers on its commitments within individual studies. The CRA role reports to Director Site Management & Monitoring (SMM), to Country Head (CH) or Associate Director, SMM.

This Job description applies to both senior and non-senior role levels with additional responsibilities and expectations applicable for the senior role, defined in document ‘Site Management and Monitoring (SM&M) Biopharmaceuticals Senior Role Definition’ (GUID-0028372).

Typical Accountabilities

Accountabilities for this role include:

• Become familiar with and perform Therapeutic Area (TA) training including relevant indication and Clinical Study Protocol (CSP) training, as required for the study.
• Contribute to the selection of potential investigators through the conduct of Site Qualification Visits.
• In some countries, and as required, is accountable for study start-up and regulatory maintenance. This may include collecting, preparing, reviewing, and tracking documents for the application process, and submitting applications/documents to Ethics Committee (EC)/Institutional Review Boards (IRB) and Regulatory Authorities for both start-up and study duration.

• Conduct Site initiation visits and throughout the study train, support, and advise investigators and site staff on study-related matters, including principles of Risk-Based Quality Management (RbQM).
• Confirm that site staff have completed and documented all required training before and throughout the study, ensuring sites remain inspection ready. 
• Actively participate in Local Study Team (LST) meetings and Investigator meetings, guarantee effective and proactive communication with all stakeholders.
• Contribute to National Investigator meetings, as applicable.
• Initiate, monitor, and close study sites in accordance with AstraZeneca Procedural Documents, sharing updates on patient recruitment and site progress within the LST.
• Drive site performance by proactively identifying and ensuring timely resolution of study-related issues, escalating where appropriate.
• Update the Clinical Trial Management System (CTMS) and other relevant systems with study site data within required timelines.
• Manage study supplies (including Investigator Study File (ISF)), drug supplies, drug accountability at study sites and prepare study drugs for destruction, where applicable.
• Perform monitoring visits (both remote and onsite) and remote data checks as specified in the relevant procedural documents and as scheduled in the study-specific Monitoring Plan including, determining the appropriate timing and type of visits in consultation with the LSAD, if needed.
• Conduct regular Site Quality Risk Assessments (SQRAs) and adjust monitoring intensity accordingly during the study.
• Collaborate with data management to maintain robust quality of collected study data by ensurin timely resolution of data queries.
• Ensure accurate and prompt reporting of Serious Adverse Events and subsequent follow-ups.
• Prepare and finalise monitoring visit reports in CTMS and provide timely feedback and follow-up letters to Principal Investigators, in accordance with required timelines and AstraZeneca procedures.
• Follow-up outstanding actions with study sites to ensure prompt resolution. 
• Adhere to quality issue processes by escalating serious or systematic quality concerns, data privacy
• issues, or compliance breaches to Local Management and/or Clinical Quality Associate Director (CQAD), as needed.
• Assist sites in maintaining an inspection-ready ISF.
• Prepare for and collaborate on activities associated with audits and regulatory inspections, in liaison with LSAD and CQAD. 
• Collect and upload essential documents into the electronic Trial Master File (eTMF) in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements, and participate in regular QC checks as performed by LSAD or delegate. 
• Ensure all documents under their responsibility are available and prepared for final archiving and completion of the local section of the eTMF. 
• Provide feedback on research-related information, including details about sites, investigators, or competing studies that may benefit the local market. 
• Ensure compliance with AstraZeneca’s Code of Ethics and with all company policies and procedures relating to people, finance, technology, security, and Safety, Health and Environment (SHE). 
• Adhere to all local, national, and regional legislation, as applicable. 
• Collaborate with local Medical Science Liaison Officers (MSLs) as directed by LSAD or line manager.

Education, Qualifications, Skills and Experience

Education and experience:

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to:  

Drug development process, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including monitoring, study drug handling and data management.

Role-Required Skills: 

• Personal Effectiveness & Drives Self-Accountability
• Learning Agility 
• Financial, Technology & Process Competency
• Active Listening, Fluency in written & spoken business-level English.
• Act with Integrity & high ethical standards.
• Effectively work as part of a team, in person and virtual settings, demonstrates cultural awareness.
• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time.
• Ability to travel nationally/internationally as required. 
• Valid driving license, if country employment requirement
• Communication & Teamwork - Impactful Site conversations
• Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management
• Ethical & Participant Safety Considerations - Interpret and Implement the Clinical Study Protocol; Adhere to Participant Rights, Privacy and Wellbeing; Participant Safety Oversight and Reporting
• Clinical Study Operations (GCP) & Quality Management - Audit & Inspection Readiness, RbQM: Interpreting and implementing the Monitoring Plan; Source Documentation and Effective Source Data Verification/Review (SDV/SDR) 
• Deliver Priorities Results & Impact: Recruitment/Retention Planning & Action.

Key stakeholders and relationships

Internal (to AZ or team) Multiple functions & departments across R&D

External (to AZ) : Research organisations and staff External professional and regulatory organizations

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.