Clinical Trials MonitorinManchesterinManchesterPUBLISHED MON 7 APR 2025
Opportunity to work at one of Europe's leading cancer centers, contributing to significant advancements in cancer research and patient care.
Engagement in a variety of clinical trials, including those with investigational medicinal products (IMPs), enhancing professional experience in diverse research methodologies.
Ability to collaborate closely with an interdisciplinary team of professionals, fostering a supportive work environment and enhancing communication skills.
Involvement in maintaining high standards of research governance, ensuring compliance with UK legislative requirements and Good Clinical Practice.
Access to ongoing professional development opportunities, including training and presentations on the latest trends and regulations in clinical trials.
Impactful role in ensuring patient safety and data integrity through the development and oversight of risk-based monitoring plans.
Competitive salary and job stability as part of a permanent position within the National Health Service (NHS), contributing to a rewarding career.
Are you passionate about the care sector and looking to enhance your career in clinical research? Join our dedicated team at Manchester University NHS Foundation Trust as a Clinical Trials Monitor. This exciting role is perfect for proactive individuals who thrive on ensuring that clinical trials are conducted to the highest standards of safety and integrity. With your background in clinical research and a strong commitment to Good Clinical Practice, you'll help us deliver excellent patient outcomes while supporting innovative cancer care.
At The Christie, one of Europe’s leading cancer centres, you’ll collaborate with a supportive team to implement monitoring strategies for our extensive portfolio of clinical trials. As you engage with trial management teams, you’ll play an essential role in risk assessment, compliance monitoring, and training the next generation of professionals in clinical research. If you're eager to make a meaningful impact in a respected institution with a focus on advancing healthcare, we’d love to hear from you. Reach out today for an informal chat or to explore the role further!
At The Christie, one of Europe’s leading cancer centres, you’ll collaborate with a supportive team to implement monitoring strategies for our extensive portfolio of clinical trials. As you engage with trial management teams, you’ll play an essential role in risk assessment, compliance monitoring, and training the next generation of professionals in clinical research. If you're eager to make a meaningful impact in a respected institution with a focus on advancing healthcare, we’d love to hear from you. Reach out today for an informal chat or to explore the role further!
Opportunity to work at one of Europe's leading cancer centers, contributing to significant advancements in cancer research and patient care.
Engagement in a variety of clinical trials, including those with investigational medicinal products (IMPs), enhancing professional experience in diverse research methodologies.
Ability to collaborate closely with an interdisciplinary team of professionals, fostering a supportive work environment and enhancing communication skills.
Involvement in maintaining high standards of research governance, ensuring compliance with UK legislative requirements and Good Clinical Practice.
Access to ongoing professional development opportunities, including training and presentations on the latest trends and regulations in clinical trials.
Impactful role in ensuring patient safety and data integrity through the development and oversight of risk-based monitoring plans.
Competitive salary and job stability as part of a permanent position within the National Health Service (NHS), contributing to a rewarding career.
Job Summary
We are inviting applications for the post of Clinical Trials Monitor.
The post holder will implement and deliver a monitoring programme to ensure that all Trust sponsored clinical trials - including those with investigational medicinal products (IMPs) are conducted according to UK legislative requirements, Good Clinical Practice and the UK Policy Framework for Health and Social Care Research.
The successful applicant will be highly motivated with a proactive approach to managing their own workload, with excellent communication and leadership skills and qualified to a higher degree level or demonstrate equivalent experience. The post holder will have experience of clinical research in the NHS. You should also have knowledge of GCP and current UK clinical trials legislation.
Main duties of the job
The post holder will be responsible for conducting GCP monitoring for Trust sponsored trials. You may also be expected to monitor other Trust-sponsored studies.
The post holder will support the risk assessment of trials to determine monitoring priorities as well as organising, preparing, conducting, reporting and follow-up monitoring visits.
You will be required to escalate issues of non-compliance to the quality manager and senior research governance manager as appropriate, following SOPs and monitoring visit report forms.
The postholder will contribute to ensuring that, as far as possible, the Trust remains 'inspection ready'. They will take a role in supporting the preparation of the organisation for statutory MHRA inspections.
We are a supportive and motivated team who strive to advance the Trust vision of providing the best patient experience, care closer to home, best patient outcomes and leading cancer care. If you have the necessary skills and abilities and would like to join our friendly team, we would like to hear from you.
We would highly recommend you contact us to arrange an informal visit or to discuss the role further.
About Us
The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Date posted
25 March 2025
Pay scheme
Agenda for change
Band
Band 7
Salary
£46,148 to £52,809 a year per annum
Contract
Permanent
Working pattern
Full-time
Reference number
413-92218-RI-AK
Job locations
R&D Office - Q
Manchester
M20 4BX
Job Description
Job responsibilities
1.0 Clinical Trials Monitoring
We are inviting applications for the post of Clinical Trials Monitor.
The post holder will implement and deliver a monitoring programme to ensure that all Trust sponsored clinical trials - including those with investigational medicinal products (IMPs) are conducted according to UK legislative requirements, Good Clinical Practice and the UK Policy Framework for Health and Social Care Research.
The successful applicant will be highly motivated with a proactive approach to managing their own workload, with excellent communication and leadership skills and qualified to a higher degree level or demonstrate equivalent experience. The post holder will have experience of clinical research in the NHS. You should also have knowledge of GCP and current UK clinical trials legislation.
Main duties of the job
The post holder will be responsible for conducting GCP monitoring for Trust sponsored trials. You may also be expected to monitor other Trust-sponsored studies.
The post holder will support the risk assessment of trials to determine monitoring priorities as well as organising, preparing, conducting, reporting and follow-up monitoring visits.
You will be required to escalate issues of non-compliance to the quality manager and senior research governance manager as appropriate, following SOPs and monitoring visit report forms.
The postholder will contribute to ensuring that, as far as possible, the Trust remains 'inspection ready'. They will take a role in supporting the preparation of the organisation for statutory MHRA inspections.
We are a supportive and motivated team who strive to advance the Trust vision of providing the best patient experience, care closer to home, best patient outcomes and leading cancer care. If you have the necessary skills and abilities and would like to join our friendly team, we would like to hear from you.
We would highly recommend you contact us to arrange an informal visit or to discuss the role further.
About Us
The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Date posted
25 March 2025
Pay scheme
Agenda for change
Band
Band 7
Salary
£46,148 to £52,809 a year per annum
Contract
Permanent
Working pattern
Full-time
Reference number
413-92218-RI-AK
Job locations
R&D Office - Q
Manchester
M20 4BX
Job Description
Job responsibilities
1.0 Clinical Trials Monitoring
- Works collaboratively with research management teams to develop/oversee and keep updated risk-based monitoring plans for all research studies sponsored and/or managed by The Christie.
- Conducts continuous monitoring activities (onsite and remote) in accordance with a monitoring plan and applicable regulatory requirement and best practice standards.
- Using analytical skills and knowledge will implement site management activities to ensure compliance with protocol, GCP, and local processes to secure data integrity and patient safety.
- Ensure appropriate Corrective Action Preventative Action plans are implemented for issues arising during monitoring visits.
- Attend the site initiation visit for all clinical trials sponsored and/or managed by the Christie where a CTU has not been engaged.
- Oversee close-out of clinical trials in accordance with relevant regulations and SOPs.
- Adhere to SOPs / work instructions to produce written reports on monitoring activities and to develop subsequent action plans for resolution of queries and ensure that they are resolved.
- Act as a point of contact for queries from research management and delivery teams regarding the ongoing conduct of clinical trials.
- Maintain regular contact with research management and delivery teams responsible for clinical trials sponsored and/or managed by The Christie by attending the team meetings (where appropriate) to ensure they have up to date information on trial progress including recruitment data.
- Build strong relationships and have direct communication with other members of the trial management team to enable smooth running of a clinical trial during its life cycle.
- Keep the Senior Research Governance Manager and quality manager informed about ongoing monitoring activities and compliance issues identified as part of monitoring visits.
- Support the pharmacovigilance function in ensuring that adverse events identified through routine monitoring activities are managed in accordance with relevant regulations.
- Support Trial Management Groups in ensuring that findings from routine monitoring activities are managed in accordance with protocol and relevant regulations.
- Maintain and develop active communicate channels with relevant stakeholders.
- Actively contribute to maintaining and building a high performing quality function that ensures the highest standards of research governance are maintained.
- Keep abreast of new developments and/or requirements for clinical trials monitoring and disseminate changes to clinical research delivery and management teams by way of presentations and/or group meetings.
- With the Research Integrity and Governance Manager, lead the design and delivery of all training pertinent to clinical trials monitoring necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio
More information related to this job opportunity, from jobsincare:
Possible interview questions for this job
Click to
viewStart practice interview
NEW!
Please wait...this will take a moment...
Please wait...this will take a moment...
More about the NHS
The National Health Service (NHS) is a cornerstone of healthcare in the United Kingdom, established in 1948 with the simple yet profound principle of providing healthcare to all citizens, free at the point of use. This revolutionary system aimed to ensure that access to medical services would not depend on an individual’s financial situation, a concept that has since become fundamental to British societal values.Learn more...
More about CANCER
Cancer remains one of the most significant health challenges in the United Kingdom, impacting millions of lives each year. According to Cancer Research UK, nearly one in two people in the UK will be diagnosed with cancer at some point in their lifetime, highlighting the pervasive nature of this disease.Learn more...
Useful skills for a Clinical Trials Monitor:
Click to view
To work as a Clinical Trials Monitor (also known as a Clinical Research Associate or CRA) in the UK, you typically need a combination of educational qualifications, professional skills, and personal attributes. Here’s a comprehensive list of key skills and qualifications:
Educational Background:
1. Degree in a Relevant Field: A bachelor’s degree in life sciences (e.g., biology, pharmacology, nursing) is often required. A master’s degree or higher in a relevant area can be advantageous.
2. Clinical Research Certification: Certification from recognized organizations (e.g., CRA certification by ACRP or SOCRA) can enhance your credentials.
Professional Skills:
1. Knowledge of GCP (Good Clinical Practice): Understanding compliance and regulatory standards governing clinical trials.
2. Clinical Trial Processes: Familiarity with all phases of clinical trials (I-IV), including study design, implementation, and close-out procedures.
3. Regulatory Knowledge: Awareness of UK-specific regulations and guidelines (MHRA, NICE) as well as EU and international requirements if applicable.
4. Data Management Skills: Ability to assess data integrity and manage clinical trial data effectively.
5. Monitoring Skills: Skills in monitoring trial sites, including site selection, initiation, routine monitoring, and close-out visits.
6. Project Management: Competence in managing timelines, budgets, and resources related to clinical trials.
7. Problem-Solving Abilities: Capacity to identify issues or deviations and implement solutions effectively.
8. Documentation and Reporting: Proficiency in maintaining accurate records, reports, and trial documentation in compliance with regulatory standards.
Technical Skills:
1. Familiarity with EDC Systems: Experience with electronic data capture (EDC) systems used in clinical trials (e.g., Medidata, Oracle's Siebel).
2. Statistical Knowledge: Understanding of biostatistics principles to interpret trial results.
Soft Skills:
1. Strong Communication Skills: Ability to convey complex information clearly to various stakeholders including investigators, site staff, and sponsors.
2. Interpersonal Skills: Building strong working relationships with site personnel and stakeholders.
3. Attention to Detail: Scrutinizing data and processes to ensure accuracy and compliance.
4. Organizational Skills: Managing multiple tasks and priorities while maintaining efficiency and accuracy.
5. Time Management: Ability to work within tight timelines and manage competing deadlines.
Personal Attributes:
1. Integrity and Ethical Judgment: Upholding high ethical standards in research practices and patient safety.
2. Flexibility and Adaptability: Being willing to travel to sites, which can involve varying hours and working conditions.
3. Self-Motivation: The ability to work independently and take initiative in managing tasks and responsibilities.
Additional Experience:
- Previous Experience: Experience in clinical research settings, even in non-monitoring roles (e.g., study coordinator, clinical research intern) can be highly beneficial.
Similar
Clinical Trials Monitorroles
More from Manchester University NHS Foundation Trust
inManchester
What might it look like to work here?
Stand by, we'll show you...
Stand by, we'll show you...
This image is not representative.
Learn more