Clinical Research Associate
$112.15k - $168.23kAstraZeneca
Are you ready to turn rigorous site execution into faster access to life-changing medicines for patients? As a Clinical Research Associate, you will be the face of AstraZeneca at investigative sites, ensuring our studies are initiated, conducted, and closed with excellence so regulators can make decisions with confidence.
In this role, you will drive the quality, speed, and integrity of clinical delivery across assigned sites. You will combine risk-based insight with hands-on partnership, building trusted relationships with investigators and site staff while keeping participant safety and data robustness at the forefront. Do you thrive on solving problems in real time and translating complex protocols into confident, compliant site performance? From day one, you will contribute to a nimble, outcome-focused team that values curiosity, accountability, and collaboration. Your impact will be tangible-measured in inspection-ready sites, reliable data, strong recruitment, and study milestones achieved on schedule. Accountabilities:- Site Readiness and Initiation: Qualify and select investigators; manage start-up activities as required, including document preparation, ethics/regulatory submissions, and site initiation. Ensure site teams complete all required training and remain inspection-ready throughout the study.
- Risk-Based Monitoring: Plan and conduct remote and onsite monitoring visits per the Monitoring Plan; perform source data verification/review; complete remote data checks; use Site Quality Risk Assessments to adjust monitoring intensity and focus on what matters most.
- Data Quality and Systems Excellence: Maintain up-to-date, accurate entries in CTMS and other systems; collaborate with data management to resolve queries promptly; prepare clear, timely monitoring reports and follow-up letters; collect and quality-check essential documents in the eTMF.
- Patient Safety Oversight: Ensure accurate and prompt reporting of Serious Adverse Events and follow-up; verify protocol adherence; safeguard participant rights, privacy, and wellbeing at every step.
- Site Performance and Recruitment: Track and drive enrollment and retention; proactively identify risks and issues; implement corrective and preventive actions; escalate appropriately; follow through to resolution to protect timelines and quality.
- Investigational Product and Materials: Manage study supplies and the Investigator Site File; oversee investigational product accountability and preparation for destruction, where applicable.
- Compliance and Inspection Readiness: Adhere to ICH-GCP, local regulations, and AstraZeneca procedures; escalate quality or compliance concerns; prepare sites and collaborate during audits and regulatory inspections.
- Stakeholder Collaboration: Engage actively with the Local Study Team and investigators; contribute to investigator meetings; communicate progress and insights; share site intelligence that informs strategy; collaborate with cross-functional colleagues as directed.
- Continuous Improvement: Identify and champion more efficient, cost- and time-optimized delivery of quality clinical trials; apply risk-based thinking to streamline processes and improve outcomes over the course of the study.
- Bachelor's degree in related discipline, preferably in life science, 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.
- 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.
- Prior experience delivering multi-center clinical studies as a CRA across phases.
- Hands-on experience with CTMS, eTMF, and risk-based monitoring, including remote monitoring approaches.
- Experience in start-up activities and submissions to Ethics Committees/IRBs and Regulatory Authorities.
- Exposure to audits and inspections with proven inspection-readiness practices.
- Certification such as ACRP-CCRA or SOCRA.
- Strong command of local language(s) in addition to English.
- Experience across multiple therapeutic areas and complex protocols.
- Comfort with data analytics or digital tools used in clinical operations.
Date Posted
27-Aug-2026 Closing Date
12-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Vacancy posted 3 days ago
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