Clinical Research Associate

SR5 2HH Sunderland, North East £55000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a leading pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their expanding operations in **Sunderland, Tyne and Wear, UK**. This hybrid role involves conducting site visits, monitoring clinical trial progress, and ensuring compliance with protocols, regulations, and Good Clinical Practice (GCP) standards. You will play a vital role in the successful execution of clinical studies, contributing to the development of life-saving medicines.

Key Responsibilities:
  • Conduct pre-study, initiation, routine monitoring, and close-out visits to clinical trial sites.
  • Verify the accuracy, completeness, and compliance of clinical data and source documents.
  • Ensure that all study-related activities are conducted in accordance with the study protocol, Investigator's Brochure, and applicable regulations.
  • Train and support investigators and site staff on study procedures and requirements.
  • Monitor patient recruitment and retention at study sites.
  • Identify, document, and escalate site issues and discrepancies to the Clinical Operations Manager.
  • Ensure timely submission of study-related documents and regulatory information.
  • Build and maintain positive relationships with clinical investigators and site personnel.
  • Prepare and present monitoring visit reports.
  • Participate in the development of study protocols and Case Report Forms (CRFs) as needed.

Qualifications:
  • Bachelor's degree in a life science, nursing, pharmacy, or related discipline; advanced degree preferred.
  • Minimum of 3 years of experience as a Clinical Research Associate or equivalent role in the pharmaceutical or biotechnology industry.
  • In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
  • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Excellent understanding of medical terminology and clinical trial processes.
  • Strong organizational, time management, and problem-solving skills.
  • Exceptional written and verbal communication skills, with the ability to interact professionally with a variety of stakeholders.
  • Ability to travel to clinical sites (approximately 50-70% travel may be required).
  • Detail-oriented with a strong commitment to data integrity and patient safety.
  • Proactive approach to identifying and resolving issues.
This hybrid position offers a competitive salary, excellent benefits, and the opportunity to advance your career in pharmaceutical research within the **Sunderland** area.
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Postdoctoral Research Associate - Durham

DH1 3LE Durham, North East Durham University

Posted 2 days ago

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Postdoctoral Research Associate - Durham

The Role and Department
You will be working as a Postdoctoral Research Assistant (PDRA) in the Bourne-Worster group, within the Department of Chemistry at Durham University, which is located on the Science Campus, a 10-minute walk away from Durham old town. The post is available for 2.5 years, including a 1-year probation period, ideally starting by March 2026 (although flexibility around this date is possible). The usual starting salary is grade 7, spine point 30 (£38,249 per year before taxes).

A World Top 100 department, the at Durham is one of the very best in the UK, with an outstanding reputation for excellence in research, teaching and employability of our students. 96% of our research outputs were rated world-leading or internationally excellent in the latest UK-wide review (REF 2021). Our Chemistry degree is among the best in the UK (5th in the Complete University Guide 2024, 10th in The Times and Sunday Times Good University Guide 2023, and 11th in the Guardian University Guide 2024). We are an active and vibrant department, with a strong cohort of early career academics and future leaders.

As a PDRA in computational chemistry at Durham, you will have access to state-of-the-art instrumentation and facilities, including Durham's High-Performance Computer, Hamilton (15,616 CPU cores, 36TB RAM and 1.9PB disk space). As part of the Northern 8 cluster, members of Durham University can also submit projects to the Tier 2 supercomputer Bede (32 IBM Power 9 dual-CPU nodes, each with 4 NVIDIA V100 GPUs and high performance interconnect). The is also well-provisioned with computational resources and you will be able to carry out much of your routine work on our two new dedicated server machines (each 64 CPU cores, NVIDIA Tesla A30 GPU unit, 384GB RAM and over 24TB storage).

The Role

This post is fixed term for 30 months, in line with funding awarded to the PI as part of her Royal Society University Research Fellowship.

You will be employed to work on research that will be led by the Principal Investigator (PI). Whilst this means that you will not be carrying out independent research in your own right, the expectation is that you will contribute to the advancement of the project, through the development of your own research ideas/adaptation and development of research protocols.

Successful applicants will, ideally, be in post by March 2026, although flexibility around this date is possible.

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Senior Clinical Research Associate

NE2 1AN Newcastle upon Tyne, North East £48000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a leading contract research organisation, is actively seeking a Senior Clinical Research Associate (CRA) to join their esteemed team, based in Newcastle upon Tyne, Tyne and Wear, UK . This critical role involves managing and monitoring clinical trials at investigational sites to ensure data integrity, patient safety, and adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities, building strong relationships with investigators and site staff, and ensuring timely completion of trial milestones. You will conduct regular site visits (both on-site and remotely as appropriate), review source documents, verify data accuracy, and manage site-specific issues. The ideal candidate will possess a comprehensive understanding of the clinical trial process, excellent organisational and communication skills, and a meticulous attention to detail. This position requires a proactive approach to problem-solving and the ability to work independently while effectively collaborating with internal study teams. This is an excellent opportunity for an experienced CRA looking to take on greater responsibility and contribute to the advancement of medical research within a supportive and professional environment.
Responsibilities:
  • Manage assigned clinical trial sites to ensure compliance with protocols and regulations.
  • Perform site initiation, interim monitoring, and close-out visits.
  • Verify accuracy and completeness of clinical data and source documentation.
  • Ensure adherence to Good Clinical Practice (GCP) and local regulations.
  • Build and maintain strong working relationships with investigators and site staff.
  • Identify and resolve site-level issues and escalate as necessary.
  • Manage drug supplies and investigational product accountability.
  • Prepare site monitoring reports and track action items.
  • Contribute to the development of study-related documents.
  • Ensure timely submission of essential documents to regulatory authorities.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related field; Advanced degree preferred.
  • Minimum of 3-5 years of direct experience as a Clinical Research Associate.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
  • Proven experience in site monitoring, data verification, and regulatory compliance.
  • Excellent interpersonal, communication, and presentation skills.
  • Strong organisational skills and ability to manage multiple priorities.
  • Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
  • Ability to travel to investigational sites as required.
  • Valid driver's license.
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Clinical Research Associate (CRA)

NE1 1BB Newcastle upon Tyne, North East £45000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a leading global pharmaceutical company dedicated to advancing medical treatments, is looking for a diligent and experienced Clinical Research Associate (CRA) to join their expanding team in Newcastle upon Tyne, Tyne and Wear, UK . This role is central to the successful execution of clinical trials, ensuring compliance with all regulatory standards and ethical guidelines. The ideal candidate will possess a strong understanding of clinical trial processes, GCP (Good Clinical Practice) regulations, and experience in site monitoring and data management. Responsibilities include identifying, selecting, and initiating clinical trial sites; conducting routine monitoring visits to assess protocol compliance, data accuracy, and patient safety; and resolving site-related issues. You will be responsible for managing relationships with investigators and study coordinators, ensuring timely drug and investigational product accountability, and preparing monitoring reports. This is a field-based role, requiring significant travel to clinical sites. We are seeking a highly organized individual with excellent communication, interpersonal, and problem-solving skills. A scientific or healthcare-related degree is required, along with demonstrable experience as a CRA or in a similar clinical trial management role. A strong understanding of the pharmaceutical industry and drug development process is essential. This is an exceptional opportunity to play a vital role in bringing life-saving therapies to patients and contributing to groundbreaking advancements in healthcare. You will be an integral part of a dedicated team focused on scientific innovation and patient well-being. Your commitment to rigorous scientific investigation will be key to our client's mission of improving global health outcomes.
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Clinical Research Associate (Pharmaceutical)

NE6 4PU Newcastle upon Tyne, North East £50000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a leading pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their expanding team. This position offers a hybrid working model, combining the flexibility of remote work with essential in-person site visits. You will be responsible for monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. Your duties will include site selection and initiation visits, conducting routine monitoring visits (remote and on-site) to assess study progress and data accuracy, and performing close-out visits. You will verify the accuracy and completeness of source documentation, reconcile investigational product accountability, and ensure adherence to study protocols by investigators and site staff. The role involves identifying, resolving, and escalating issues encountered at clinical sites, and providing training and guidance to site personnel. You will also be responsible for managing study documentation, ensuring its timely submission and archiving. The ideal candidate will possess a strong understanding of drug development processes, clinical trial methodology, and regulatory guidelines within the pharmaceutical industry. Excellent organizational skills, attention to detail, and the ability to manage multiple priorities are essential. You must be comfortable travelling to clinical sites as required. Strong communication and interpersonal skills are crucial for building effective relationships with investigators, site staff, and internal project teams. This role requires a proactive approach to problem-solving and a commitment to maintaining the highest standards of data integrity and patient safety.
Qualifications:
  • Life science degree (e.g., Pharmacy, Biology, Nursing) or equivalent scientific background.
  • Minimum of 3 years of experience as a Clinical Research Associate.
  • Thorough knowledge of ICH-GCP guidelines and regulatory requirements.
  • Experience in monitoring clinical trials across various therapeutic areas.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Excellent written and verbal communication skills.
  • Strong organizational and time management abilities.
  • Willingness and ability to travel to clinical sites (up to 50%).
  • Ability to work independently and as part of a collaborative team.
  • Valid driver's license and access to a reliable vehicle for site visits.
This role is located in **Newcastle upon Tyne, Tyne and Wear, UK**, with a hybrid working arrangement.
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Clinical Research Associate (CRA)

SR5 2 Sunderland, North East £40000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a leading pharmaceutical organisation, is seeking a dedicated Clinical Research Associate (CRA) to join their expanding clinical operations team. This role is crucial for ensuring the quality, integrity, and ethical conduct of clinical trials. You will be responsible for monitoring study sites, ensuring compliance with protocols, and managing data collection. This position offers a hybrid working arrangement, requiring some on-site presence in the Sunderland, Tyne and Wear, UK area, with flexibility for remote work between site visits.

Key Responsibilities:
  • Conduct site selection, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) and relevant regulations.
  • Ensure study protocols, drug accountability, and investigational product are managed appropriately at clinical sites.
  • Verify the accuracy, completeness, and integrity of clinical data through source document verification.
  • Serve as the primary point of contact for assigned clinical trial sites, fostering positive relationships with investigators and site staff.
  • Identify and report protocol deviations, adverse events, and safety concerns in a timely manner.
  • Train and mentor site staff on study procedures, protocol requirements, and data collection.
  • Prepare and present study progress reports to the project team and management.
  • Ensure timely resolution of site-specific issues and action items.
  • Maintain accurate and up-to-date trial documentation in the Trial Master File (TMF).
  • Contribute to the development and review of study-related documents, such as protocols and case report forms (CRFs).

Qualifications and Experience:
  • Bachelor's degree in a life science, nursing, pharmacy, or a related field.
  • Minimum of 2 years of direct experience as a Clinical Research Associate.
  • Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements.
  • Experience with various therapeutic areas is a plus.
  • Excellent monitoring skills, with a keen eye for detail and accuracy.
  • Strong written and verbal communication skills.
  • Ability to manage multiple priorities and work independently within a hybrid team structure.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Willingness to travel to clinical sites as required.
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Clinical Research Associate (Remote)

NE30 1HN Newcastle upon Tyne, North East £50000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a pioneering pharmaceutical company at the forefront of medical innovation, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their expanding team. This is a fully remote position, allowing you to contribute from anywhere in the UK while being an integral part of vital drug development processes. You will be responsible for monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures, and Good Clinical Practice (GCP) guidelines. This role is crucial for the successful progression of life-changing therapies from research to market.

Core Responsibilities:
  • Perform site selection, initiation, monitoring, and close-out visits to ensure compliance with protocols and regulations.
  • Verify the accuracy and completeness of clinical data through source document verification (SDV).
  • Ensure proper investigational product (IP) management at trial sites.
  • Act as the primary point of contact for clinical trial sites, providing guidance and support to investigators and site staff.
  • Monitor subject recruitment and retention efforts.
  • Identify, document, and track deviations from protocol and GCP.
  • Prepare monitoring reports and action plans in a timely manner.
  • Collaborate with internal teams, including project managers, data managers, and medical monitors.
  • Ensure all trial-related documentation is maintained accurately and according to regulatory standards.
  • Participate in trial team meetings and contribute to the overall success of clinical trials.
Essential Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
  • Proven experience as a Clinical Research Associate, with a strong understanding of ICH-GCP guidelines.
  • Demonstrated ability to conduct site monitoring visits and manage multiple trial sites independently.
  • Excellent understanding of clinical trial processes and regulatory requirements.
  • Strong organizational, communication, and interpersonal skills.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to work autonomously and manage time effectively in a remote setting.
  • Commitment to patient safety and data integrity.
  • Willingness to travel to sites as required (typically up to 60%).
This remote-first opportunity offers exceptional flexibility and the chance to contribute to groundbreaking pharmaceutical research. If you are a meticulous and motivated CRA looking for a challenging and rewarding career, we want to hear from you.
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Senior Clinical Research Associate (Remote)

SR1 2TT Sunderland, North East £60000 Annually WhatJobs

Posted today

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full-time
Our client, a leading organisation in the non-profit sector dedicated to advancing healthcare solutions, is seeking a highly skilled and experienced Senior Clinical Research Associate (CRA). This is a pivotal, fully remote role contributing to groundbreaking research initiatives. You will be responsible for the oversight and management of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. Your role will involve site selection, initiation, monitoring, and close-out activities, all performed remotely. The ideal candidate possesses extensive experience in clinical research, a thorough understanding of Good Clinical Practice (GCP) guidelines, and exceptional organisational and communication skills. You will play a crucial part in the successful execution of studies that aim to improve patient outcomes.

Key Responsibilities:
  • Perform remote monitoring of clinical trial sites to ensure compliance with study protocols, Standard Operating Procedures (SOPs), and regulatory requirements.
  • Conduct remote pre-study visits, initiation visits, interim monitoring visits, and close-out visits.
  • Verify the accuracy, completeness, and integrity of clinical data through remote source data verification (SDV).
  • Ensure accurate and timely reporting of study progress, site status, and any identified issues.
  • Provide training and guidance to investigators and site staff on study-related procedures and documentation.
  • Manage study timelines and ensure the timely recruitment of participants.
  • Maintain effective communication with investigators, site staff, internal project teams, and regulatory authorities.
  • Ensure investigational product accountability and management at study sites.
  • Prepare monitoring reports and action plans for site issues.
  • Stay up-to-date with current regulations and guidelines in clinical research.
  • Contribute to the development and review of study-related documents, such as protocols and case report forms (CRFs).
Required Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
  • A minimum of 5 years of experience as a Clinical Research Associate, with substantial experience in remote monitoring.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
  • Proven experience in managing multiple clinical trial sites simultaneously.
  • Excellent understanding of medical terminology and clinical trial procedures.
  • Exceptional organisational, time management, and problem-solving skills.
  • Strong written and verbal communication skills, essential for effective remote interaction.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to work independently, maintain a high level of detail, and manage workload effectively in a remote setting.
  • Experience in therapeutic areas relevant to our client's research focus is a plus.
  • Commitment to ethical research practices and patient safety.
This is a significant opportunity for a seasoned Senior CRA to contribute to vital healthcare research in a fully remote capacity, offering flexibility and impact. Our client provides a supportive environment and competitive remuneration for dedicated professionals. The original posting location was **Sunderland, Tyne and Wear, UK**.
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Senior Clinical Research Associate (Remote)

SE1 1AA Sunderland, North East £55000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a leading global pharmaceutical company, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dedicated team. This is a fully remote position, offering the flexibility to work from anywhere within the UK. You will play a crucial role in the successful execution of clinical trials, ensuring compliance with regulatory standards and company policies.

Responsibilities:
  • Perform all activities related to the monitoring of clinical trials in compliance with protocol, GCP, and regulatory requirements.
  • Identify, evaluate, and qualify study sites; initiate, monitor, and close-out study sites as assigned.
  • Conduct on-site and remote monitoring visits to assess patient safety, data integrity, and protocol adherence.
  • Ensure accurate and timely entry of study data into electronic data capture (EDC) systems.
  • Manage site-level study documentation and maintain essential regulatory files.
  • Build and maintain strong working relationships with investigators, site staff, and internal project teams.
  • Identify and report potential protocol deviations, adverse events, and safety concerns in a timely manner.
  • Participate in the development and review of study-related documents, such as protocols, informed consent forms, and investigator brochures.
  • Provide training and guidance to site staff on study procedures and regulatory requirements.
  • Manage study supplies and drug accountability at assigned sites.
  • Contribute to the overall success of clinical trial management by ensuring efficient site operations and data quality.
Qualifications:
  • Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
  • Minimum of 5 years of experience as a Clinical Research Associate, with a strong understanding of GCP and regulatory guidelines.
  • Proven experience in monitoring various phases of clinical trials.
  • Excellent knowledge of medical terminology and clinical trial processes.
  • Proficiency in using EDC systems and other clinical trial management software.
  • Exceptional organizational, time management, and problem-solving skills.
  • Strong written and verbal communication skills, with the ability to effectively interact with diverse stakeholders.
  • Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote environment.
  • A valid driver's license and willingness to travel for site visits as required (typically 50-70% travel, though the role is remote-based).
This is an exceptional opportunity to contribute to cutting-edge pharmaceutical research while enjoying the autonomy and flexibility of a remote role. Our client offers a comprehensive benefits package and opportunities for career advancement.
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Lead Clinical Research Associate (Remote)

NE1 4BN Newcastle upon Tyne, North East £65000 Annually WhatJobs

Posted 5 days ago

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full-time
Our client, a globally recognized pharmaceutical company at the forefront of medical innovation, is actively seeking an experienced Lead Clinical Research Associate (CRA) to join their expanding clinical operations team. This is a fully remote position, offering the flexibility to work from home while playing a crucial role in the successful execution of clinical trials. You will be responsible for overseeing site management, ensuring compliance with regulatory standards, and safeguarding the integrity of trial data.

Key Responsibilities:
  • Lead and manage clinical trial sites, ensuring adherence to Good Clinical Practice (GCP) guidelines, protocols, and regulatory requirements.
  • Conduct site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs) to assess site readiness, compliance, and data accuracy.
  • Train and mentor site staff on trial protocols, procedures, and data collection requirements.
  • Oversee the recruitment and retention of participants, working closely with investigators and site personnel.
  • Ensure timely collection, verification, and source data verification (SDV) of all clinical trial data.
  • Manage investigational product (IP) accountability and distribution at study sites.
  • Identify and report adverse events (AEs) and serious adverse events (SAEs) promptly, ensuring appropriate follow-up.
  • Resolve site-level issues and discrepancies, escalating critical matters as needed.
  • Prepare monitoring reports and maintain accurate and complete trial documentation.
  • Collaborate with internal teams, including project managers, medical monitors, and data managers, to ensure seamless trial execution.
  • Contribute to the development of study protocols and other clinical trial documents.
  • Stay current with industry regulations, trends, and best practices in clinical research.
Qualifications:
  • Bachelor's degree in a life science, nursing, or a related field; Master's degree is a plus.
  • Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotechnology industry.
  • Demonstrated experience in a lead or supervisory role within clinical operations.
  • In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
  • Proven ability to effectively monitor clinical trial sites and ensure data integrity.
  • Strong organizational, time management, and problem-solving skills.
  • Excellent interpersonal and communication skills, with the ability to build rapport with site staff.
  • Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to work independently and manage a remote workload effectively.
  • Willingness to travel occasionally for site visits and training as required (though the role is primarily remote).
This is a fully remote position. The conceptual headquarters for this role is **Newcastle upon Tyne, Tyne and Wear, UK**. If you are a dedicated and experienced CRA looking for a challenging remote opportunity within the pharmaceutical sector, we encourage you to apply.
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