clinical trials of medicinal products and all aspects of pharmaceutical input in accordance with legal requirements and GoodClinicalPractice (GCP) relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) advanced therapy investigational products (ATIMPs) and non - investigational medicinal products … Takes responsibility for the provision, management and development of a high quality, comprehensive specialist clinical trials pharmacy service 5.1. Works according to GCP guidelines and agreed pharmacy clinical trials procedures. 5.2. Critically appraises clinical trials protocols, including amendments, to assess feasibility and ensure all pharmaceutical aspects of … Pharmacy, or relevant postgraduate experience Demonstrates continued professional development or equivalent knowledge through extensive experience Awareness of GoodClinicalPractice (GCP) Desirable Attendance at relevant regional and national Clinical trials courses/meetings Member of relevant specialist pharmacist group Current GCP certification. Teaching/Mentoring more »
and demonstrate that high quality data is being collected and that the trial is being conducted according to the ethically approved protocol and ICH-GCP standards. They will also coordinate data collection and data entry and responding to everyday queries from research nursing team and study participants including coordination and … delivery of a comprehensive, high-quality service within the CRF in accordance with Trust Policies, R&D SOPs, GoodClinicalPractice (GCP) and all other regulatory requirements. *To contribute to the implementation, monitoring, improving and management of the CRF's Operations, policies and SOP and support its … in touch with the contact for this role. Person Specification Qualifications Essential Science graduate or equivalent level of Knowledge and experience Desirable Recent ICH GCP Training Experience Essential Experience of working in a clinical research environment within NHS, University or pharmaceutical industry Experience of working with multi-disciplinary teams. more »
progress research to improve patient care? We are looking for a hard-working, enthusiastic pharmacist who shares our Trust values to join our expanding clinical trials and research team at Mersey Care NHS Foundation Trust. Mersey Care is at the forefront of clinical trials for mental health, putting … of pharmacist as required3.Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of GoodClinicalPractice (GCP), Good Manufacturing Practice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management.4.To participate in the Trust-wide Out of Hours Medicines Advice … in Clinical Pharmacy, willingness to work towards or equivalent experience Registration with General Pharmaceutical Council Desirable Membership of the Royal Pharmaceutical Society (RPS) GCP training Knowledge/Experience Essential Demonstrable evidence of commitment to self development and CPD Experience of undertaking audit within pharmaceutical services Understanding of how medicines more »
policies and ensuring studies have all relevant approvals. In addition, you will play a key role in the performance, co-ordination and working alongside clinical teams in the set up of research studies. Attention to detail and the ability to work both as part of a team and autonomously … to name just a few. Job description Job responsibilities PRINCIPAL RESPONSIBILITIES To plan and coordinate your day-to-day work in collaboration with Senior Clinical Research Facilitator. To be responsible for robust and accurate data systems of research studies. Input to governance strategies. Support and assist in the development … appropriate understanding of the studies and trial documentation. To enter data onto the appropriate databases in relation to research governance studies. Work according to GCP and research governance standards for all aspects of work practice. Coordinate commercial studies under the supervision and support of senior colleagues. Adhere to research governance more »
Will be the Radio pharmacy expert and professional resource for the multi-disciplinary team. Ensure all Radio pharmacy work complies with statutory regulations and goodpractice codes; the latter including. The EU Guidance on Good Manufacturing Practice (GMP)/Rules and Guidance for Pharmaceutical Manufacturers and … pharmacy service, organising and implementing complex short, medium and long term plans in response to legislative and regulatory changes, infrastructure developments, evolving consensus of goodpractice and the availability of new diagnostic tests and treatments. About us Northampton General Hospital is one of the largest employers in the … room design, equipment and function. Understanding of Validation & Quality guidance including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) GCP knowledge and training RPS training Skills Essential Able to prioritise workload/flow of Leaders and team workers, methodical and organised, self-motivated and able more »
Job summary We are looking to appoint a consultant in Clinical Oncology with a special interest in the medical management of Gastrointestinal (GI), Neuroendocrine (NET) and Urological malignancies. The successful candidate will work with existing Medical and Clinical Oncology colleagues, clinical nurse specialists, nurse and pharmacist prescribers … job To provide a cancer service to patients with GI, NET and Urological malignancies throughout the trust and referral region. Maintenance of the highest clinical standards in the management of oncology To work with colleagues at Oxford University Hospital NHS Foundation To provide a cancer service to patients with … Communication skills should be highly developed Experience of teaching undergraduates and trainees Evidence of effective participation in clinical audit and risk management. ICH GCP training within last 12 months. Evidence of active involvement in clinical research trials. Desirable Management training and experience Knowledge of the organisation of the more »
Senior Clinical Biochemist STATUS: Full Time LOCATION: Onsite in Yorkshire, England DEPARTMENT: Laboratory SCHEDULE: Tuesday to Saturday; Day Shift SUMMARY As a seasoned Scientist IV in Clinical Biochemistry, you will play a vital role within our Laboratory team. … Your responsibilities encompass the meticulous analysis of clinical samples across automated and manual platforms, adhering strictly to GoodClinicalPractice (GCP) standards. Joining our esteemed international organization offers more than just a job — it's an opportunity for professional growth and development. Supported by visionary leadership … empowering you to shape our organization and chart your career trajectory. ATTRIBUTES: • BSc in Biomedical Sciences or equivalent. • Minimum of 6 years' experience in clinical biochemistry. • Proven expertise and proficiency in assays/platforms within the laboratory setting. KEY RESPONSIBILITIES Analysis: Conduct thorough analysis of clinical trial samples more »
Job summary We are offering an exciting opportunity for suitable applicants to join the pharmacy clinical trials team at the Sheffield Teaching Hospital NHS Foundation Trust. The Clinical Trials team is expanding its workforce to increase research at Sheffield teaching hospitals. The Trust is one of the busiest … to demonstrate knowledge of clinical trial processes, including relevant legislation and local policies (Band 6) Able to demonstrate specialist clinical trials knowledge (GCP,GMP), relevant or applicable to the job role, underpinned by theory or relevant practical experience (Band 5 & 6) Developed IT skills Desirable (Band 5) Able … to demonstrate knowledge of clinical trial processes, including relevant legislation and local policies (Band 5) Able to demonstrate specialist clinical trials knowledge (GCP,GMP), relevant or applicable to the job role, underpinned by theory or relevant practical experience (Band 5) Appropriate Short Management Courses e.g. Appraisal training, Leadership more »
University Hospitals Birmingham NHS Foundation Trust
Desirable *Appropriate professional qualification or knowledge of legal procedures and contracts gained through experience Experience Essential *Understanding of GoodClinicalPractice (GCP) and the EU clinical trials directive *Knowledge of Common law of Confidentiality, Data Protection Act 2018 and GDPR. *Experience of report writing and managing …/analysing complex data. Desirable *In-depth understanding of clinical research and trial management methodology, including applicable regulatory requirements. *Significant Operational management experience working within a NHS environment working with clinicians and other health care professionals at all levels of the organisation *Writing Data Protection Impact Assessments (DPIAs) *HR … of normal office hours; *Ability to travel across all of UHB sites and to external sites if required. Desirable *Ability to propose changes to practice and lead on service development for specialist area, developing and implementing policy for that area. Propose changes in conjunction with service groups which have more »
field of Data Sciences and Artificial Intelligence. This will be a supervised work theme exploring the use and analysis of big healthcare data for clinical decision making in emergency General Surgery as well as exploring the acceptability to patients of using healthcare data for research in Artificial Intelligence. The … successful applicant will work closely with the General Surgery, Colorectal and HPB surgical teams at Manchester Royal Infirmary as well as the Clinical Data Sciences Unit at MFT. The candidate will be expected to register for a higher degree with the University of Manchester which will be co-supervised … with all research governance processes as set by the MFT Research & Innovation Department Maintain an up-to-date GoodClinicalPractice (GCP) in Research for the duration of the post The successful applicant will also be expected to register for the degree of MD/PhD at more »
Cambridge University Hospital NHS Foundation Trust
resources available. You should be able to demonstrate experience of successfully managing an operational service as well as having recent experience of leading in clinical or research innovation and working in collaboration across professions and services. Sound knowledge and experience of genomics within maternity or paediatric services is desirable. … focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe … Analysis, interpretation and use of information Time Management Able to react under pressure Knowledge Essential An understanding of issues surrounding research, including patient confidentiality, goodclinicalpractice and research governance Comprehensive knowledge and understanding of NHS policy and strategy with a proven ability to translate into local more »
Job summary The post holder will lead the provision of a high quality, safe and effective pharmacy clinical trials service, to ensure compliance with the required National Standards and UHBResearch and Development Strategy. The post holder will be the Pharmacy Lead Facilitator for Research and Audit projects. They will … own professional actions and deliver a high quality specialisedclinical pharmacy service to promote the safe, rational and cost-effective use of drugs,through personal practice and the training of other staff. The post holder will contribute to the training and education for Undergraduate HealthProfessionals and Post-Graduate Pharmacists, Nurses … Health Board's Research & Development department and, supported by our highly experienced Senior Pharmacy Trials Technician, will provide expert regulatory knowledge with regards to GCP and pharmaceutical aspects of clinical trial delivery and management. The ideal applicant will be a highly motivated and methodical pharmacist who is able to more »
studies across all specialities. The team comprises of more than 50 dedicated and experienced members of staff this includes researchers, research nurses, research governance, clinical trials assistants and research support staff. Working in the research team, you will be joining a driven and caring department looking to enhance the … high-quality research sponsorship function. Provide expertise regarding research regulatory requirements, i.e., NHS Research Ethics Committee, HRA, MHRA, ICO, FDA, Research Governance Framework, ICH-GCP, and advise accordingly. Manage the development of systems which enable the recording and tracking of research approval and delivery timelines in accordance with institutional and … systems and structures. Ensure that all research carried out in the Trust complies with the UK Policy Framework for Health & Social Care Research, ICH GCP standards and best practice, including MHRA guidance. Advise on the development of research protocols and policies for RM&S and input into policies at more »
referred for ophthalmic research participation assisting with the coordination and delivery of planned health care as part of observational/data collection and interventional clinical trials. Supporting ERGO in contributing to the effective quality of care for patients, taking part in observational and interventional clinical research. Coordinate assigned … research studies alongside the Investigators and Research Nurses Active involvement with recruitment of clinical trial participants and to assist in the provision of information and support to patients and families embarking upon study … participation. Assist with weekly excel overview of potential AMD study participants and screening procedures in AMD/macular and diabetic eye clinics. According to GCP guidelines - training is given to allow the Research Assistant to undertake the informed consent procedure for observational/data collection studies Maintain confidentiality of information more »
a meaningful impact on people's lives. Main duties of the job Why Join Us? At Likewise our Independent Prescribers are essential in implementing goodclinical practices and pharmacological/health interventions. When you become a part of our team, you'll benefit from: Work/Life Balance … Flexible working hours to suit your needs. Clinical Support: Regular clinical supervision, appraisal, and revalidation support. Professional Growth: Generous CPD time to enhance your skills and knowledge. Leave Benefits: Generous annual leave entitlement (27 days, plus bank holidays, increasing to 32 after 1 year's service). Team … our impact reporthereto read more about the important work that we have done. Job description Job responsibilities Job purpose:To deliver drug and alcohol clinical and prescribing services to the service population. Key accountabilities: 1. Clinical assessment with or without Prescribing a range of medications (including controlled drugs more »
following SOPs: To co-ordinate the day to day workload, ensuring items are manufactured in a timely manner and colleagues are supported. To follow good manufacturing practice (GMP) at all times. To generate worksheets and labels, ensuring medicines are charged correctly using the pharmacy computer system. To in … Full Science Manufacturing Technician Level 3 Standard Registered Pharmacy Technician or Registered Science Manufacturing Technician Desirable Aseptic Preparation and Dispensing of Medicines Skills Essential Good communication skills Computer skills (dispensing, stock control) Use of Microsoft office applications, e.g. excel, word … Knowledge and Experience Essential In depth understanding of GMP. Knowledge of practice in hospital Aseptic Services Experience of final checking Desirable Experience of GCP/setting up clinical trials within an aseptic unit Experience of creating debtor forms, dealing with invoice queries. Experience of conducting risk assessments and more »
bioanalytical studies. 3. A working knowledge and practical experience using LC-MS/MS. Key Words: Small Molecule | Study Manager | Team Lead | Bioanalysis | GLP | GCP | Method Development | Validation | Sample Analysis | Regulatory Compliance | LC-MS/MS Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
responsibility for duties including: Designs and oversees the implementation quality management systems for CMC development activities including the release of product for GLP and GCP studies. Provides quality expertise in accordance with the global quality requirements in the creation of product characterisation, product specifications, method validation, stability and comparability assessments … in the collaboration with C(D)MOs. Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review more »
Responsibilities Participate in pre-clinical and clinical bioanalytical projects through method development, validations and routine sample analysis in accordance with GLP and GCP regulations. Experience of running LC-MS/MS and or LBS s including equipment maintenance and troubleshooting. Experience in running Ligand Binding Assays. Deliver projects … as part of a team Demonstrate knowledge of GLP/GCP and conduct all work in a manner that is compliant to regulatory requirements Qualifications and experience A degree in life science or chemistry-related field Hands-on experience with LC-MS/MS and Ligand Binding assays is desired … good communicator with strong interpersonal skills. Has a delivery focus with a good work ethic. Experience in working in a GLP/GCP accredited facility Knowledge of software-specific platforms is preferred Benefits Competitive Salary Pension Scheme Private Healthcare Generous Holiday Package Career Progression Opportunities more »
Maidenhead, Berkshire, United Kingdom Hybrid / WFH Options
Confidential
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over … processes in place. As an experienced CRA you'll be involved in initiation, routine & close out visits for studies in Phases II - IV of clinical development. Successful candidates will enjoy the benefits of working for a company that values work-life balance. Other Information: This role is a full … employed through Fortrea. For more information please contact Magdalena Koz owska, Recruiter at Key words: Clinical Research, SCRA, Clinical Research Associate, London GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, Oncology, Field Based, Home Based, CRO, Pharmaceutical, London Fortrea is actively seeking motivated problem-solvers and more »
Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »
Macclesfield, Cheshire, North West, United Kingdom
Russell Taylor Group Ltd
via literature searches. Providing an indication of any potential difficulties with bioanalytical methods and assisting with client calls and visits. Working to GLP/GCP and showing good documentation practice. The Person A successful candidate will have previous experience working in a regulatory bioanalysis lab with experience performing LC … experience of using LC-MS/MS. Previous experience of troubleshooting Have previous experience performing sample extraction techniques for biological analysis. Must be a good communicator with excellent interpersonal skills. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this more »
capability for the handling of dangerous human pathogens and animal modelling of infectious diseases. The capability is used to understand pathogenesis and undertake pre-clinical development and assessment of new vaccines and therapeutics. The capability is also used to undertake studies in microbiological aerobiology, decontamination, and detection, and to … commercial projects on behalf of vaccine manufacturers. The Group has extensive experience in assay development and validation and operates to several Quality Systems including GCP, GLP and GMP. Main duties of the job Job description The purpose of this job is to perform routine duties related to and to provide … placements, or taught course Experience or understanding of working in a laboratory environment Experience or understanding of working within a regulated environment (e.g., ISO9001, GCP) and safe working practices Desirable Criteria Good knowledge and practical experience with specialist techniques for project i.e., working in a containment level 3 laboratory more »
We are seeking a dynamic senior Study/Trial Manager (CSPM) to lead our clinical trials with precision and expertise for a period of 6 months. As a senior member of our clinical operations team, you will be responsible and accountable for the operational delivery of our clinical … of complex clinical trials from inception to completion. · Develop and manage comprehensive study timelines, budgets, and resources. · Ensure strict compliance with regulatory requirements, GCP, and ICH guidelines. · Lead cross-functional teams, including CRAs, data managers, biostatisticians, and other key stakeholders. · Monitor study progress, identifying and resolving issues to maintain … field; advanced degree (e.g., MSc, PhD, MD) preferred. · Minimum of 5-7 years of experience in clinical trial management. · In-depth knowledge of GCP, FDA regulations, and ICH guidelines. · Demonstrated ability to deliver multiple, complex studies simultaneously. · Exceptional organisational and project management skills. · Strong leadership and team management capabilities. more »
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over … Fortrea is transforming drug and device development for partners and patients across the globe. Job overview: Provides strategic direction and oversight of Quality Assurance GCP Audit and Inspection operations and assures that audit program aligns with global RCQA strategies. Oversees external sponsor and inspectorate evaluations assuring follow up on trends … drive strategic business process improvement initiatives Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. more »