22 Durham University jobs in Durham
Clinical Research Associate
NE1 4AA Newcastle upon Tyne, North East
£40000 Annually
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Posted 3 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a dedicated Clinical Research Associate (CRA) to support groundbreaking medical research. This role, based in **Newcastle upon Tyne, Tyne and Wear, UK**, offers a hybrid working model, combining essential in-office presence with the flexibility of remote work. You will play a vital part in the planning, implementation, and monitoring of clinical trials, ensuring adherence to protocol, Good Clinical Practice (GCP), and regulatory standards. Responsibilities include site initiation, monitoring, and close-out visits, data verification, and regulatory documentation management. The ideal candidate will possess a strong scientific or healthcare background, excellent organisational skills, and meticulous attention to detail. Experience as a CRA or in a related clinical research role is highly desirable. You should be proficient in understanding clinical trial protocols and able to effectively communicate with investigators, site staff, and internal project teams. A proactive approach to problem-solving and a commitment to patient safety are paramount. You will be expected to travel to clinical sites as required, undertaking site audits and ensuring the quality and integrity of trial data. This position offers an excellent opportunity to contribute to the development of new medicines and therapies within a highly respected organisation. You will benefit from a supportive team environment and opportunities for professional development in the dynamic pharmaceutical industry. Strong written and verbal communication skills are essential. Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is advantageous.
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0
Clinical Research Associate (Remote)
SR1 2BP Sunderland, North East
£45000 Annually
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Posted today
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Job Description
Our client, a rapidly growing pharmaceutical company dedicated to advancing life-saving therapies, is looking for a meticulous and experienced Clinical Research Associate (CRA) to join their expanding remote workforce. This position offers the flexibility of working entirely from home, allowing you to contribute to critical clinical trials across the UK. As a CRA, you will be the primary point of contact for study sites, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines. Your core responsibilities will include site selection and initiation, regular monitoring visits (remote and on-site as required, though this role is designed for remote focus), source data verification, and ensuring the accuracy and completeness of clinical trial documentation. You will also be responsible for tracking study progress, identifying and resolving site issues, and ensuring timely data entry and query resolution. The ideal candidate will possess strong organizational skills, exceptional attention to detail, and a thorough understanding of the drug development process and regulatory requirements. You must be adept at building strong relationships with investigators and site staff, fostering collaboration and compliance. This role demands excellent communication and interpersonal skills, as well as the ability to work independently, manage your time effectively, and meet tight deadlines in a demanding, fast-paced environment. Join us and be a vital part of bringing new medicines to patients.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Perform remote monitoring activities to ensure compliance with study protocols and regulatory requirements.
- Conduct site visits as necessary for initiation, monitoring, and close-out phases.
- Verify the accuracy, completeness, and integrity of clinical data against source documents.
- Ensure all clinical documentation is maintained in accordance with GCP and company SOPs.
- Act as a liaison between study sites, the clinical operations team, and other departments.
- Identify, track, and resolve site-level issues and discrepancies.
- Prepare and present monitoring visit reports in a timely manner.
- Contribute to the development and review of study-related documents.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- Thorough knowledge of GCP, FDA regulations, and clinical trial processes.
- Proven experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent organizational, analytical, and problem-solving skills.
- Strong written and verbal communication abilities.
- Ability to travel as required for essential site visits (though the primary focus is remote).
- Demonstrated ability to work independently and manage time effectively.
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1
Clinical Research Associate (CRA)
NE1 8QB Newcastle upon Tyne, North East
£40000 Annually
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Posted 2 days ago
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Job Description
Our client, a leading pharmaceutical company, is looking for a dedicated Clinical Research Associate (CRA) to join their esteemed clinical operations team in Newcastle upon Tyne, Tyne and Wear, UK . This hybrid role offers a blend of remote work and on-site visits to clinical trial sites. You will play a crucial role in ensuring the smooth and efficient conduct of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. Your primary responsibilities will involve monitoring clinical trial sites to verify the accuracy and integrity of data, ensuring patient safety, and confirming compliance with study protocols. This includes performing site initiation visits, regular monitoring visits (both on-site and remote), and site close-out visits. You will be responsible for source data verification, reviewing case report forms (CRFs), and identifying and resolving data discrepancies in a timely manner. Building and maintaining strong relationships with principal investigators and site staff is essential for the success of this role. You will also be responsible for tracking study progress, managing essential study documents, and ensuring that all trial-related activities are conducted and documented according to the approved protocol and company policies. The ideal candidate will possess a Bachelor's or Master's degree in a life science, nursing, or a related field, coupled with at least 2 years of direct experience as a CRA or in a similar clinical research role. A thorough understanding of ICH-GCP guidelines and regulatory frameworks governing clinical trials is mandatory. Excellent organizational skills, strong attention to detail, effective communication and interpersonal abilities, and proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems are vital. You must be adaptable, able to manage your time effectively, and willing to travel to sites as needed. This is an excellent opportunity to contribute to life-saving research and advance your career in the pharmaceutical industry with a supportive and innovative organization.
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2
Clinical Research Associate - Pharmaceutical
NE27 0BG Newcastle upon Tyne, North East
£40000 Annually
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Posted 2 days ago
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Job Description
Our client is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their pharmaceutical team in Newcastle upon Tyne . This role is field-based, requiring regular travel to clinical sites within the designated territory to ensure the proper conduct of clinical trials according to protocol, regulatory requirements, and Good Clinical Practice (GCP). You will be responsible for site selection, initiation, monitoring, and close-out visits. This involves verifying the accuracy and completeness of clinical data, ensuring the safety of trial participants, and maintaining essential trial documentation. A key part of your role will be to build and maintain strong working relationships with investigators, site staff, and internal study teams. You will also be tasked with identifying and addressing site-level issues, providing training to site personnel, and ensuring compliance with all study-related procedures. The ideal candidate will possess a strong understanding of clinical trial processes, regulatory guidelines (e.g., FDA, EMA), and pharmaceutical industry standards. Excellent organizational, communication, and interpersonal skills are essential for success in this position. You must be able to work independently, manage your time effectively, and demonstrate a high level of accuracy and attention to detail. Previous experience as a CRA or in a similar clinical research role is highly desirable. A background in life sciences, nursing, or a related healthcare field is preferred. The ability to travel extensively within the Newcastle upon Tyne region and occasionally further afield is a requirement for this position.
Key Responsibilities:
Key Responsibilities:
- Conduct site visits (initiation, interim monitoring, close-out) to ensure trial protocols are followed.
- Verify the accuracy, completeness, and integrity of clinical data.
- Ensure compliance with GCP, regulatory requirements, and study protocols.
- Manage study site relationships and provide necessary training to site staff.
- Monitor patient safety and report adverse events promptly.
- Maintain essential trial documentation and records.
- Identify and resolve site-specific issues and discrepancies.
- Collaborate with study teams to ensure timely data collection and query resolution.
- Prepare monitoring reports and follow up on action items.
- Support site audits and regulatory inspections.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
- Minimum of 2-3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial monitoring role.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience with clinical trial documentation and data management.
- Strong understanding of medical terminology and clinical trial processes.
- Excellent organizational, time management, and problem-solving skills.
- Proficiency in English, with strong written and verbal communication skills.
- Ability to travel regularly (up to 60-70%) within the assigned territory.
- Valid driver's license and a clean driving record.
- Demonstrated ability to work independently and collaboratively.
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3
Clinical Research Associate - Pharmaceutical
SR1 1AA Sunderland, North East
£40000 Annually
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Posted 3 days ago
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Job Description
Our client, a leading pharmaceutical company at the forefront of medical innovation, is seeking a diligent and experienced Clinical Research Associate (CRA) to join their team in Sunderland, Tyne and Wear, UK . This role operates on a hybrid model, allowing for effective collaboration while maintaining flexibility. You will play a critical role in the successful execution of clinical trials, ensuring compliance with regulatory standards and protocols. Your responsibilities will include site initiation, monitoring, and closing visits to ensure the quality, integrity, and accuracy of data collected. You will be responsible for verifying patient records, source documents, and adherence to study protocols and Good Clinical Practice (GCP) guidelines. Building strong relationships with investigators and site staff, providing training on study procedures, and resolving any site-related issues are key aspects of this role. The ideal candidate will possess a strong background in clinical research, with a degree in life sciences, nursing, or a related field. Essential qualifications include a thorough understanding of ICH-GCP guidelines and regulatory requirements, coupled with excellent communication, organisational, and problem-solving skills. Previous experience as a CRA, either directly or within a similar clinical research role, is highly desirable. You must be meticulous, detail-oriented, and capable of managing multiple sites and priorities effectively. This is an exceptional opportunity to contribute to the development of life-saving medicines and advance your career within a dynamic and supportive pharmaceutical environment. Our client is committed to scientific excellence and offers excellent opportunities for professional growth and development.
Responsibilities:
Responsibilities:
- Conduct site visits (initiation, monitoring, close-out) according to study protocols and SOPs.
- Ensure compliance with ICH-GCP guidelines and all applicable regulatory requirements.
- Verify accuracy and completeness of clinical trial data and source documentation.
- Train and support study site personnel on study procedures and protocols.
- Build and maintain strong working relationships with investigators and site staff.
- Identify and address site-specific issues and deviations.
- Prepare visit reports and follow up on action items promptly.
- Assist in the selection and qualification of new clinical trial sites.
- Contribute to the overall quality and integrity of clinical trial data.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Proven experience as a Clinical Research Associate (CRA) or similar role.
- In-depth knowledge of ICH-GCP guidelines and clinical trial processes.
- Excellent monitoring, organisation, and time management skills.
- Strong communication, interpersonal, and problem-solving abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required.
- Attention to detail and a commitment to data quality.
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4
Senior Clinical Research Associate
SR1 1AA Sunderland, North East
£65000 Annually
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Posted 3 days ago
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Job Description
Our client is seeking a highly skilled Senior Clinical Research Associate (CRA) to join their expanding pharmaceutical research division. This is a fully remote role, offering the flexibility to work from home across the UK. 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), and applicable regulatory requirements. Your key duties will include site selection, initiation, monitoring, and close-out visits; verifying data accuracy and completeness; ensuring adherence to Good Clinical Practice (GCP) guidelines; and resolving any issues that arise during the trial. You will also maintain effective communication with study sites, investigators, and internal project teams, and contribute to the preparation of study documentation. The ideal candidate will possess a strong understanding of clinical trial phases, regulatory guidelines (e.g., FDA, EMA), and ICH-GCP. Proven experience as a CRA, ideally with a background in pharmaceutical or biotech companies, is required. Excellent organizational, analytical, and problem-solving skills are essential, as are strong interpersonal and communication abilities to build effective relationships with study sites. A Bachelor's degree in a life science or healthcare-related field is mandatory; a Master's degree or PhD is advantageous. Experience with various therapeutic areas is preferred. This remote position provides an excellent opportunity to advance your career in clinical research, contributing to the development of life-saving medicines while enjoying the benefits of a remote work environment.
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5
Clinical Research Associate (CRA)
NE1 4AG Newcastle upon Tyne, North East
£45000 Annually
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Posted 3 days ago
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Job Description
Our client, a prominent pharmaceutical company, is seeking a dedicated Clinical Research Associate (CRA) to join their clinical operations team. This position requires your presence at our facilities and clinical sites, based primarily in the **Newcastle upon Tyne, Tyne and Wear, UK** region, with travel expected. As a CRA, you will play a pivotal role in ensuring the quality and integrity of clinical trials by monitoring study conduct at investigative sites. Your key responsibilities will include site selection, initiation visits, routine monitoring visits, and close-out visits, ensuring compliance with protocol, GCP, and regulatory requirements. You will be responsible for reviewing and verifying case report forms (CRFs), source documents, and trial-related records. Building and maintaining strong relationships with investigators and site staff is crucial for success. The ideal candidate will have a Bachelor's degree in a life science, nursing, or a related field, coupled with at least 2-3 years of experience as a CRA or in a similar clinical research role. A thorough understanding of ICH-GCP guidelines and regulatory requirements is essential. Excellent communication, organizational, and time-management skills are a must. You should be comfortable with extensive travel to clinical sites. This is an excellent opportunity for an experienced CRA to contribute to the development of life-changing medications within a leading pharmaceutical organization. If you are passionate about clinical research and meet the qualifications, we encourage you to apply.
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6
Senior Clinical Research Associate
NE1 4JQ Newcastle upon Tyne, North East
£55000 Annually
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Posted 6 days ago
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Job Description
Join a pioneering pharmaceutical company dedicated to developing life-changing therapies, as a Senior Clinical Research Associate (CRA). Based in our state-of-the-art facility in Newcastle upon Tyne, Tyne and Wear , this hybrid role offers a blend of remote flexibility and essential on-site engagement. You will play a critical role in ensuring the quality, integrity, and compliance of clinical trials, from site initiation to close-out. Your expertise will directly contribute to bringing innovative medicines to patients faster.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Conduct pre-study, initiation, interim monitoring, and close-out visits for clinical trial sites to assess regulatory compliance and protocol adherence.
- Ensure accurate and timely collection of clinical data, verify source documents, and manage data discrepancies.
- Manage investigational product accountability and ensure proper storage and handling at study sites.
- Act as the primary liaison between the sponsor and the clinical trial sites, fostering strong relationships and addressing site needs promptly.
- Train and mentor site staff on protocol requirements, data collection, and regulatory compliance.
- Prepare and submit comprehensive monitoring visit reports and follow-up letters.
- Identify and report adverse events and protocol deviations according to established procedures.
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and company SOPs.
- Contribute to the development and review of study-related documents, including protocols, case report forms (CRFs), and informed consent forms.
- Participate in team meetings and contribute to the overall success of clinical development programs.
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 in the pharmaceutical or biotechnology industry.
- Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements.
- Demonstrated experience in monitoring multiple therapeutic areas.
- Excellent organizational, communication, and interpersonal skills.
- Ability to travel to clinical trial sites as required (up to 60%).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong attention to detail and ability to manage multiple priorities effectively.
- Ability to work autonomously and as part of a collaborative team in a hybrid environment.
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7
Clinical Research Associate - Oncology
SR1 1YS Sunderland, North East
£50000 Annually
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Posted 12 days ago
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Job Description
Our client, a pioneering pharmaceutical company at the forefront of medical innovation, is seeking a highly skilled and dedicated Clinical Research Associate (CRA) to support their vital oncology clinical trials. This is a fully remote position, allowing you to contribute to life-changing research from anywhere within the UK. As a CRA, you will be responsible for monitoring clinical trial sites, ensuring compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Your role will involve site initiation, routine monitoring visits, close-out activities, and the verification of data accuracy and integrity. You will play a crucial part in the drug development process, working closely with investigators, study coordinators, and internal teams to ensure patient safety and data quality. The ideal candidate will have a strong background in clinical research, with specific experience in oncology trials. Excellent knowledge of GCP, regulatory affairs, and clinical trial processes is essential. You must possess exceptional organizational skills, meticulous attention to detail, and the ability to manage multiple priorities effectively in a remote setting. Strong interpersonal and communication skills are vital for building rapport with site staff and fostering collaborative relationships. This role offers the opportunity to work on cutting-edge therapies and make a tangible difference in the lives of patients battling cancer. If you are a motivated and experienced CRA passionate about advancing oncology research and seeking a rewarding, fully remote career opportunity, we encourage you to apply.
Key Responsibilities:
Key Responsibilities:
- Conduct site initiation, monitoring, and close-out visits.
- Ensure compliance with study protocols, SOPs, and regulatory guidelines (GCP, ICH).
- Verify the accuracy, completeness, and consistency of clinical data.
- Monitor patient safety and report adverse events promptly.
- Manage study site operations and resolve site-level issues.
- Build and maintain strong relationships with investigative site staff.
- Prepare monitoring reports and communicate findings to project teams.
- Ensure timely submission of essential documents.
- Contribute to the development of study-related documents.
- Proven experience as a Clinical Research Associate, preferably in oncology.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Experience with clinical trial site management and monitoring.
- Excellent understanding of clinical trial processes and documentation.
- Strong analytical, organizational, and time-management skills.
- Exceptional communication and interpersonal abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Bachelor's degree in a life science, nursing, or a related healthcare field.
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8
Senior Clinical Research Associate (CRA)
NE1 0AB Newcastle upon Tyne, North East
£45000 Annually
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Posted today
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Job Description
Our client is seeking an experienced Senior Clinical Research Associate (CRA) to join their expanding pharmaceutical research team in Newcastle upon Tyne, Tyne and Wear, UK . This vital role involves overseeing and managing clinical trials at investigational sites, ensuring compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will be responsible for site selection, initiation, monitoring, and close-out activities, building strong relationships with investigators and site staff. Key duties include conducting site visits (pre-study, initiation, interim, and close-out), verifying data accuracy and integrity, ensuring proper documentation, and managing investigational product accountability. The ideal candidate will have a strong understanding of clinical trial phases, therapeutic areas, and regulatory landscapes. Excellent communication, organizational, and problem-solving skills are essential, as is the ability to work independently and manage multiple priorities effectively. You will also be responsible for identifying and resolving site issues, training site personnel, and contributing to study start-up and closure processes. This role requires meticulous attention to detail and a commitment to ethical research practices. A significant portion of the role will involve travel to clinical sites across the region and potentially further afield.
Key Responsibilities:
Required Qualifications:
Key Responsibilities:
- Conduct site monitoring visits to assess study progress and compliance.
- Ensure adherence to clinical trial protocols, SOPs, and GCP guidelines.
- Verify the accuracy, completeness, and quality of clinical data.
- Manage investigational product and study supplies at sites.
- Provide training and ongoing support to site staff.
- Identify and resolve issues related to clinical trial conduct.
- Prepare and maintain essential study documents.
- Facilitate regulatory inspections and audits.
- Contribute to study team meetings and communicate site status.
Required Qualifications:
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate.
- Thorough knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience in site management and monitoring.
- Excellent communication, interpersonal, and organizational skills.
- Ability to travel to clinical sites as required.
- Strong problem-solving and critical thinking abilities.
- Proficiency in clinical trial management software.
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