92 Clinical Research Associate (CRA) courses

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The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

Reasons to attendThis Junior CRA training will train you in the basic, yet crucial areas within clinical monitoring. All typical tasks of a Clinical Research Associate (CRA) will become clear to you, from selecting the investigators until study site close-out, with a great focus on the “monitoring practice” and an introduction on the impact of digitalization. What's included? Documents and materials related to this course are included Globally recognised certificates awarded after test completion This course has been granted PharmaTrain Recognition

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

How to increase your odds of finding a job in Clinical Research?This STAR Programme will provide the capabilities you need to become a Junior Clinical Researcher. Most employers will require practical experience on the job before considering your application. At ECCRT, we realise that this situation limits the inflow of young, intelligent, and motivated people. To further develop your potential, this STAR Programme combines a series of training and practical internships during a period of one year.

Explore the intricacies of Clinical Research Administration with our comprehensive course on Protocols and Ethics. Gain expertise in trial design, ethical considerations, regulatory compliance, and more. Prepare for a future in clinical research with practical insights and knowledge. Enroll now for a rewarding journey in advancing healthcare through responsible and ethical clinical trials.

Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 14 Points Development Level Develop

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Certificates CPD Accredited Hard Copy Certificate Hard copy certificate - Included If you are an international student, you will be required to pay an additional fee of 10 GBP for international delivery, and 4.99 GBP for delivery within the UK, for each certificate CPD Accredited Digital Certificate Digital certificate - Included

Reasons to attendHow to ensure a successful clinical trial within timelines and budget? This Clinical Project Management training is a blended course (eLearning + Classroom or Webinars) designed to introduce the ins and outs of managing clinical research projects. The clinical study setting allows you to implement this knowledge immediately within your research projects.What's included? Documents and materials related to this course are included Globally recognised certificates awarded after test completion This course has been granted PharmaTrain Recognition

Overview Explore the intricacies of clinical research and understand the administration process with our Clinical Research Administration Training course. This course will help you deepen your knowledge and acquire the ability to seek career prospects in the relevant sectors. The course is packed with high;y valuable information on clinical research. From the informative modules, you will learn the core concepts of clinic trial designing and planning. The course will help you develop the skills for data management and analysis. You will be able to build your expertise in monitoring and auditing. Moreover, you will acquire the skills required for quality control and site management as well. After the course, you will receive a CPDQS-accredated certificate of achievement. This certificate will enhance your employability and help you reach your career goals. Enrol now! Course Preview Learning Outcomes Understand the significance of clinical research in healthcare Learn about the process of clinical trail design and planning Deepen your knowledge of ethics and regulatory compliance Develop the ability for data management and record-keeping Know how to monitor and audit the trials Grasp the process of study site management and quality control Why Take This Course From John Academy? Affordable, well-structured and high-quality e-learning study materials Engaging tutorial videos, materials from the industry-leading experts Opportunity to study in a user-friendly, advanced online learning platform Efficient exam systems for the assessment and instant result Earn UK & internationally recognised accredited qualification Easily access the course content on mobile, tablet, or desktop from anywhere, anytime Excellent career advancement opportunities Get 24/7 student support via email. What Skills Will You Learn from This Course? Trail planning Data management and analysis Monitoring and auditing Site management Quality control Compliance management Who Should Take This Clinical Research Administration Training? Whether you're an existing practitioner or an aspiring professional, this course is an ideal training opportunity. It will elevate your expertise and boost your CV with key skills and a recognised qualification attesting to your knowledge. Are There Any Entry Requirements? This Clinical Research Administration Training course is available to all learners of all academic backgrounds. But learners should be aged 16 or over to undertake the qualification. And a good understanding of the English language, numeracy, and ICT will be helpful. Certificate of Achievement After completing this course successfully, you will be able to obtain an Accredited Certificate of Achievement. Certificates & Transcripts can be obtained either in Hardcopy at £14.99 or in PDF format at £11.99. Career Path​ This exclusive Clinical Research Administration Training course will equip you with effective skills and abilities and help you explore career paths such as  Clinical Research Administrator Clinical Research Associate Clinical Research Coordinator Clinical Data Manager Module 01: Introduction to Clinical Research Administration Introduction to Clinical Research Administration 00:15:00 Module 02: Clinical Trial Design and Planning Clinical Trial Design and Planning 00:11:00 Module 03: Ethics and Regulatory Compliance Ethics and Regulatory Compliance 00:13:00 Module 04: Institutional Review Boards (IRBs) and Ethics Committees Institutional Review Boards (IRBs) and Ethics Committees 00:10:00 Module 05: Data Management and Recordkeeping Data Management and Recordkeeping 00:12:00 Module 06: Safety Reporting and Adverse Events Safety Reporting and Adverse Events 00:10:00 Module 07: Clinical Trial Monitoring and Auditing Clinical Trial Monitoring and Auditing 00:09:00 Module 08: Study Site Management and Quality Control Study Site Management and Quality Control 00:17:00 Module 09: Data Analysis and Reporting Data Analysis and Reporting 00:09:00 Module 10: The Future of Clinical Research The Future of Clinical Research 00:10:00 Certificate and Transcript Order Your Certificates and Transcripts 00:00:00