1 to 25 of 57 Good Clinical Practice Jobs

our pharmacy department. The successful candidate will have the opportunity to develop expertise in clinical trials procedures, Good Clinical Practice (GCP), and relevant regulations. Banding will be dependent on qualifications and prior experience. With demonstrated competency and continuous professional development, there is a clear and automatic … South (PWDS) Accredited Checking Technician (or equivalent) or willing to work towards this once in post Will complete Good Clinical Practice (GCP) training and willing to maintain certification every 3 years as per Trust Policy once in post Working towards Pharmacy Leadership Programme or equivalent or be … ongoing competence in leadership skills Desirable Completed Pharmacy Workforce Development South (PWDS) Accredited Checking Technician (or equivalent) Completed Good Clinical Practice (GCP) and willing to maintain certification every 3 years as per Trust Policy Completed Pharmacy Leadership Programme or equivalent or be able to demonstrate ongoing competence more »

Job summary An exciting opportunity has arisen for a Specialist Clinical Trials & Cancer Services Pharmacist to join the Cancer and Aseptic Services team at ESHT. The successful candidate will lead on a portfolio of cancer & non-cancer clinical trials undertaken … within ESHT. They will appraise all relevant clinical trials & offer pharmaceutical input in accordance with legal requirements & Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage & disposal of investigational medicinal products (IMPs) & non-investigational medicinal products (NIMPs). They will also contribute to … the delivery of a high quality specialist clinical pharmacy service to cancer clinical services. Experience in Cancer &/or Aseptic Services is essential. They will not only have the opportunity to explore & enhance their clinical expertise, but will also be developing management, training & leadership skills. They will more »

Associate Director Quality Assurance SUMMARY: The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical Trials … Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred. RESPONSIBILITIES: Leadership. Strategic partnership with Global Quality Assurance team and Global Leadership Team Regional oversight of Quality Assurance teams Daily management activities for … Maintenance of a working knowledge of industry and regulatory standards and requirements Provision of guidance and leadership on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standards Responsive escalation point for Clinical Trials quality issues and more »

Background must be in pharma NOT medical devices) Senior R&D QA GCP Auditor (pharmaceuticals) I'm looking to recruit a seasoned Senior R&D QA GCP Auditor responsible for ensuring compliance and proper implementation of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice … the clinical development of Global R&D projects in the UK and EU settings. The ideal candidate should possess substantial experience as a GCP-GCLP auditor in pharmaceutical firms or Contract Research Organisations (CROs), as well as relevant experience in managing clinical trials involving investigational medicinal products as … managing audit results (non-conformities). the Unit Head's responsibilities in gathering data to aid in the annual audit program's preparation for GCP and GCLP auditing activities. in keeping the yearly audit programme for GCP and GCLP auditing operations updated and monitored. pertaining to GCP-GCLP auditing operations more »

trials coordination and data management involving clinical trials or project co-ordination, as well as a good understanding of clinical research, GCP and clinical governance. We are looking for individuals with excellent organisation and communication skills, who can work well both in a team and using … support to the senior R&I management and clinical research staff, and ensure compliance with Trust Policy, Good Clinical Practice (GCP) and all other relevant requirements. About us The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We … Research Nurse Team Leader/Research Manager. Person Specification Qualifications Essential Scientific/Business degree or relevant experience in scientific and medical research. Current GCP certification. Desirable Post graduate certificate in clinical research or other relevant post graduate qualification/experience. Management qualification. Experience Essential Line management experience Significant more »

R&D team to cover a 12 months maternity leave vacancy. You will work alongside a colleague to manage patient data relating to the clinical research outcomes of patients cared for with Metabolic disorders. You will be involved in all aspects of clinical trials, including research study set … roles and when that happens we sometimes bring the closing date forward, so please apply promptly to avoid disappointment. Person Specification Qualifications Essential NIHR Good Clinical Practice Trained A Degree or Equivalent experience within Research Knowledge & Nature of Experience Essential Previous experience in setting up and coordinating … in the NHS Practical knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice (GCP) Desirable Previous experience in Research Grant/Commercial study costing processes Knowledge of the Data Protection Act in relation to research and clinical care more »

is to support the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies. The post-holder will be responsible for supporting the delivery of clinical trials within the Clinical … assigned team, under the guidance of the Clinical Research Nurse Team Leader. Maintain investigator site files and essential documentation in accordance with ICH GCP and Trust SOPs to ensure they are always kept inspection ready. Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety … system. Able to assess and interpret clinical/non-clinical information. Knowledge Essential Knowledge of the clinical trials process. Familiar with GCP guidelines/EU directives Desirable Knowledge of issues relevant to paediatric research. Knowledge of patient information systems. Skills Essential Good organisational skills Good more »

provide medical support to the Early Phase Trials team including consultants, nursing and administration staff by primarily acting as co-investigator on early phase clinical trials. The successful applicant will join a highly … motivated and empowered workforce to increase research capacity and deliver innovative early phase research in compliance with Good Clinical Practice (ICH-GCP) and Trust policy. This is a 10 session non-training post funded through The Clatterbridge Cancer Centre for an initial period of 1 year (potential … to extend to 2 years). The Early Phase Clinical Research Fellow role is suitable for individuals towards the end of, or having completed, their specialist oncology training who wish to gain further experience in experimental medicine and Phase I trials, including first-in-human trials, clinical pharmacology more »

Medicines Administration (ePMA) system at Walsall Healthcare NHS Trust. They will also play a key role in the implementation and ongoing management of all clinical digital systems involving medicines and work closely with the Pharmacy IT, Digital Services, wider pharmacy teams and clinical staff across the Trust to … ensure that clinical digital solutions are developed and maintained to reflect the current and future needs of the organisation. Main duties of the job The post holder will: Support the implementation and further development of an Electronic Prescribing and Medicines Administration (ePMA) system across the Trust, and They will … from system suppliers, the Trust IT department, NHS Digital and other system providers, To maintain own training in Good Clinical Practice (GCP) to be able to fulfill requirements for providing pharmacy input to system configuration and developments. Person Specification Qualifications Essential Masters Degree in Pharmacy (or equiv. more »

of documentation for Ethical Approval and the NIHR CSP and EDGE process To establish trial site files for each trial in accordance with ICH-GCP and research governance. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the study protocol … Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries Have a solid understanding of … the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes Ensure safety data is reported to required more »

plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and continuously improving the site's … Qualifications Bachelor’s degree (preferred) 3+ years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization (required) Demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA (strongly preferred) Certified Quality Auditor (preferred) RESPONSIBILITIES Quality Assurance Responsibilities: Ensure the efficiency of the Quality System/personnel for the … Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised GLP, GCP, EMA, FDA, and OECD guidelines or regulations. Provide support/host customer-initiated audits, mock regulatory inspections, and regulatory facility inspections. Participate in the review more »

that we offer, and the successful applicant will work with the Research Governance group to continue to develop our research programme and with the clinical teams on service development and data management projects. Main duties of the job Be a professional role model and research champion for the organisation. … Team: Hospice Care Team Group: Care Reports to: Nurse Consultant Paediatric Palliative Care Hours: 37.5 hours (Split between Specialist PalliAtive CarE (SPACE) team and Practice Education team) 3 days within the hospice, 2 days remote working Level: Band 7 £50,921.91 - £55,184.02 (geographical allowance included) Location: Christophers, Guildford … the successful applicant will be required to work with the Research Governance group to continue to develop our research programme, strategy and with the clinical teams service development and data management projects. This role is able to be offered as a hybrid working pattern with 3 days in the more »

Sponsors to provide safe and efficient delivery of studies. Working with the unit teams and medical leads to create and maintain a culture of clinical excellence, process improvement, effective leadership and high standards of volunteer/patient care. KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED: A minimum of 4 years … experience working within a Senior Strategic Management role, along with a good understanding of Clinical Operations. A minimum of 7 years’ experience within the field of clinical trials, Early Phase preferred, or relevant clinical setting RGN/RMN or BSc Nursing/Biomedical or BSc … in a scientific field would be highly desirable RESPONSIBILITIES: Departmental operational oversight of business activities at the Early Phase Unit in accordance with ICH-GCP, MHRA Phase 1 Accreditation, MAC SOPs and Study specific protocols whilst optimising profitability by leading the MAC teams to meet/exceed business projections. Lead more »

well established QA function. KEY RESPONSIBILITIES: Coordinating the implementation of the company's quality management system pertaining to Good Clinical Practice (GCP), including oversight of external vendors, training on quality procedures, and performance monitoring against established standards. Serving as the main point of contact and providing support … Supporting the planning and execution of audits, including those conducted internally, at vendor sites, clinical sites, external laboratories, and suppliers. Providing guidance on GCP/GCLP/GLP practices to clinical project teams and identifying/mitigating operational risks and deviations. Overseeing Change Controls, Deviations, and Corrective and … any findings. Delivering training to laboratory teams as needed. Experience Needed: Minimum 4+ years of experience in the pharmaceutical/biotechnology industry in a GCP QA role, with experience in providing quality support to clinical laboratories. Experience in providing quality support for Cell or Gene Therapy programs is highly more »

Clinical Data Manager – £35,000-£47,000 per annum– Liverpool/Hybrid The Role Do you have a keen eye for detail and a knack for ensuring data accuracy? Are you excited about using cutting-edge AI to transform healthcare? MyCardium AI, a rapidly growing company using AI to … revolutionise cardiac MRI analysis, is seeking a highly motivated Clinical Data Manager to join our team in Liverpool. In this pivotal role, you will oversee the collection, management, and analysis of imaging data from clinical trials. You'll ensure data quality and integrity, working closely with a dynamic … clinical data management, ideally in imaging. Experience with imaging data and software (PACS, DICOM). Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Proficiency in data management software and databases. Strong understanding of clinical trials and regulations. Excellent organisation and communication skills. Ability to more »

ensure correct data collection 3. To be responsible for forwarding trial data in a timely manner to the trial co-ordinating centre. Liaise with clinical trial personnel outside the hospital as necessary. 4. To assist in the review of trial protocols and identify resource implications for the site. 5. … To check eligibility of patients into trials and to ensure that all relevant data has been recorded 6. To take responsibility for liaising with Clinical Trials Units regarding data queries and for checking and resolving data queries 7. To contribute to the development of clinical and research policies … assist with where appropriate the establishment and maintenance of trial site files for trials in accordance with ICH good clinical practice (GCP) and Research Governance 10. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the protocol more »

Quality Assurance Manager - Good Clinical Practice Our client, based in Cheshire are recruiting for a contract GCP QA Manager to join them for a 6 month project. This is an exciting opportunity to join a dynamic company with a great culture. Role: Provide strategic direction for quality … CAPA Process to ensure effectiveness Support the development of a risk based audit programme Maintain network of external audit providers to support CMC, pre-clinical and clinical activities. Support the management, implementation, and maintenance of the Quality Management System to support clinical development … activities. Support senior management in providing direction and leadership to staff to ensure a quality mindset is embedded in the business Requirements: Expert in GCP with working knowledge of GMP 5 years experience in a QA Manager role within a CRO, Biotech or Pharma company Contract: Hours: 3 days a more »

coordination all clinical trial functions within aseptic services to meet the needs of the service. Ensure compliance to procedures and national standards (GMP, GCP and The Medicines for Human Use (Clinical Trials) Regulations 2004). About us Cardiff and Vale University Health Board is one of the largest … communication and interaction skills. NVQ L3/BTEC Pharmacy services Good working knowledge of safe dispensing and aseptic practices Knowledge and understanding of GCP/GMP legislation and QA and its application to aseptic processing Able to demonstrate excellent organisational skills Good attention to detail and responsible attitude … quality and accuracy Experience in Clinical Trials day to day running of service, attending meetings, co-ordinating aspects related to organisation of trials GCP/GMP legislation (including preparation for inspection), clinical trial set-up and management, manufacture of IMPs and QP release, clinical trials in specialist more »

Job summary An exciting opportunity has arisen for anenthusiastic and motivated band 4/5 pharmacy technicians to work as part of our pharmacy clinical trials team here at University Hospitals Southampton NHS Foundation Trust. Experience and knowledge of ICH good clinical … practice and being a current holder of ACPT accreditation would be an advantage but is not essential.These permanent posts require specialist training in GCP and IMP management. You will work as a Senior Technician in Clinical Trials Pharmacy and must be committed to providing the highest quality of … specialities. You will be responsible in setting up trials, ensuring that trials run smoothly; this will include accurate record keeping and drug accountability of clinical trials, reviewing protocol specific guidelines and liaising within a multi-disciplinary team. You will need to be able to multitask, possess excellent communication skills more »

Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies. May perform safety reviews of clinical trial protocols, Investigator’s Brochures, clinical study reports, informed consent forms, and other study related documents. Participates on Global Patient Safety (GLPS) teams … World Education & Experience BA/BS or advanced degree in life sciences or related field with some experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Or PharmD or PhD in a scientific field. Knowledge & Other Requirements Demonstrated ability to be a fast learner. … Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP). Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly-matrixed more »

The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … good clinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »

Associate Director of GCP | Permanent | Hybrid - Oxford | Circa £95k We are currently working on a new Associate Director of Good Clinical Practice position at a super exciting pharmaceutical startup client based in Oxford. They are looking for someone to come and and be the right-hand person … deputising for them, sharing responsibility and leading the team when required. The ideal person will have strong QA and managerial experience within pharma and GCP, someone who is willing to be hands-on and into the detail expected when operating within a startup environment. Responsibilities: Ensuring GCP is maintained and … to senior leadership and represent QA in reporting What you will bring: Roughly 7+ years working in a leadership QA position Outstanding knowledge of GCP, TFA and FDA regulations Strong management skills A desire to be hands-on and into the thick of things Logistics: Salary of around more »

Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that … assessments, etc.) Other duties as needed. Maintain awareness of and ensure compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP). Experience required A Degree and/or or appropriate relevant work experience. 2 years’ experience working in more »

The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … good clinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »

The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … good clinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »