26 Durham University jobs in Durham
Clinical Research Associate
Posted 10 days ago
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Job Description
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.
Postdoctoral Research Associate - Durham
Posted 2 days ago
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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.
Senior Clinical Research Associate
Posted 10 days ago
Job Viewed
Job Description
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.
- 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.
Clinical Research Associate (CRA)
Posted 10 days ago
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Job Description
Clinical Research Associate (Pharmaceutical)
Posted 10 days ago
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Job Description
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.
Clinical Research Associate (CRA)
Posted 10 days ago
Job Viewed
Job Description
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.
Clinical Research Associate (Remote)
Posted 10 days ago
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Job Description
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.
- 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%).
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Senior Clinical Research Associate (Remote)
Posted today
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Job Description
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).
- 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.
Senior Clinical Research Associate (Remote)
Posted 4 days ago
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Job Description
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.
- 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).
Lead Clinical Research Associate (Remote)
Posted 5 days ago
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Job Description
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.
- 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).