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AstraZeneca
United States · remote · USD 112154.4-168231.6 annual
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.
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.
Apply on source siteListed via Himalayas
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, 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.
Personal Effectiveness & Drives Self-Accountability
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.
Join a science-led organization where your fieldwork directly accelerates decisions that bring new medicines to people who need them. You will collaborate closely with colleagues across development, often bringing diverse experts together to challenge ideas and move faster with balanced risk. We value curiosity alongside accountability and kindness; leaders remove barriers so you can focus on what matters—patient safety, data quality, and timely delivery. With modern tools, a culture that welcomes bold thinking, and opportunities to grow across varied projects, your contributions will shape both our pipeline and your career.
Seize this opportunity to elevate your impact—help deliver confident, fast approvals by turning exceptional site execution into better outcomes for patients and your own growth.
The annual base pay (or hourly rate of compensation) for this position ranges from $112,154.40 - $168,231.60 USD Annual, either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Closing Date
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.
Originally posted on Himalayas