Clinical Research Associate

AstraZeneca; Wilmington (DE); On-site; USD 112,000 - 168,000; Full time

Job summary

AstraZeneca is seeking a Clinical Research Associate to act as the face of the company at investigative sites, ensuring initiation, conduct, and closeout of studies with excellence for regulator confidence.

You will monitor quality, speed, and integrity of clinical delivery, building trusted relationships with investigators while prioritizing patient safety and data robustness. The role requires travel and cross‑functional collaboration.

Qualifications

• Bachelor's degree required; life sciences preferred.
• Strong knowledge of ICH-GCP, regulations, and drug development processes.
• Experience with clinical study management, monitoring, data management, and study drug handling.

Responsibilities

• Qualify and select investigators; manage start-up activities and ethics/regulatory submissions.
• Plan and conduct remote and on-site monitoring per the Monitoring Plan; perform SDV/SDR.
• Maintain accurate entries in CTMS/eTMF and collaborate with data management.
• Ensure safety reporting of Serious Adverse Events and protocol adherence.
• Track enrollment and retention; identify risks and implement CAPAs.
• Oversee investigational product accountability and site materials.
• Ensure inspection readiness and compliance with AstraZeneca procedures.
• Collaborate with Local Study Team; communicate progress and insights.
• Identify opportunities to improve efficiency and reduce costs in trial delivery.

Skills

Communication

Fluent English

Risk-based monitoring

Site collaboration

Problem solving

Travel readiness

Education

Bachelor's degree in life sciences

Tools

CTMS

eTMF

Job description

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; elevate 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; elevate 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.

Essential Skills/Experience

• 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.

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.

Desirable Skills/Experience

• 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.

Why AstraZeneca

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.

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.