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Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 2 mins ago
Engineering Operation Technician
Amazon Data Services, Inc.
Wharton, TX
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with…
Added 11 mins ago
BA
Solutions Architect
Booz Allen Hamilton
Aurora, CO
- $99,000 to $225,000 USD / year
Experience designing, modifying, developing, writing, and implementing software programming applications using agile methods
Added 11 mins ago
BA
Modeling and Simulation Engineer
Booz Allen Hamilton
Colorado Springs, CO
- $86,800 to $198,000 USD / year
Design and tailor software solutions using high-level programming language such as Java, C++, and Python to inform modeling, wargaming, operational concepts and force design…
Added 11 mins ago
UO
Finance and Accounting Senior Professional
University of Colorado Denver
Boulder, CO
- $34,986 USD / year
The Department of Earth Science (formerly Geological Sciences) at CU Boulder encourages applications for a Finance and Accounting Senior Professional! This position serves as a financial…
Added 11 mins ago
BA
Computer Vision AI Engineer
Booz Allen Hamilton
Colorado Springs, CO
- $99,000 to $225,000 USD / year
Develop and maintain Fire Control Systems, ensuring robustness and accuracy in real-time applications.
Added 11 mins ago
UO
Mechanical Engineer II
University of Colorado Denver
Boulder, CO
- $34,986 USD / year
Uses FEA software, ideally ANSYS or NASTRAN, to perform basic analysis
Added 11 mins ago
UO
CIRES / NOAA Chemical Sciences Laboratory, Post-Doctoral Associate or Research S
University of Colorado Denver
Boulder, CO
- $65,000 to $84,450 USD / year
The Cooperative Institute for Research in Environmental Sciences (CIRES) at CU Boulder encourages applications for a Post-doctoral Associate or Research Scientist 1 position within the…
Added 11 mins ago
AE
Generative AI / Internal Tools Development
Apogee Engineering
Colorado Springs, CO
- $65,000 to $100,000 USD / year
…suite. You'll design, prototype, and ship production-ready applications that streamline workflows for teams across the company often using Generative AI and agentic AI approaches to…
Added 11 mins ago
TT
Implementation Consultant
Tyler Technologies
Lakewood, CO
- $59,451 to $90,000 USD / year
…clients on proofing and analyzing data conversions from existing software to Tyler…

AstraZeneca

Senior Clinical Research Associate

Wilmington, DE, United States
Wilmington, United States

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Job details

Apply by: May 5, 2027
Experience: Minimum of 4 years of CRA monitoring experience
Posting language: English
Posted: Nov 6, 2026

Original job description

This is what you will do:

The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The Sr. CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The Sr. CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study. The Sr. CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. A Sr. CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg. Lead CRA, etc).

You will be responsible for:

Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalate them as appropriate.
Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans.
Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs.
Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include 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.
Contributing to the nomination and selection of potential investigators and assisting with feasibility activities
Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed.
Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to PMCO, Director COM, HCO and/or Quality Group as required.
Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with PMCO, Director COM, and Quality Group.

You will need to have:

Minimum of 4 years of CRA monitoring experience
Bachelors degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Excellent knowledge of relevant local regulations.
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
Good understanding of the drug development process.
Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
Excellent attention to detail.
Excellent written and verbal communication skills.
Excellent collaboration and interpersonal skills.
Good negotiation skills.
Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
Valid driving license

We would prefer for you to have:

Ability to work in an environment of remote collaborators and in a matrix reporting structure
Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to 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.
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Proactivity and assertive when communicating with internal stakeholders and sites
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 flexible; ability to respond quickly to shifting demands and opportunities.
Experience in all study phases and in rare medical conditions preferred.

Date Posted 06-Nov-2026 Closing Date 19-Nov-2026Our 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.

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More about this job

Skills

Clinical research
Collaboration
Project management
Operations management
COM
Regulatory compliance
Google Cloud
Quality assurance procedures
Recruitment
Data entry
Inspection
Good manufacturing practices
Data management
Attention to detail
Communication skills
Interpersonal skills
Negotiation
Reporting
Clinical trials
Computer skills

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