Improving the patient's quality of life is one of the objectives of healthcare and, to achieve this, we must make every effort in research"

The creation of new drugs allows us to survive new pathologies, diseases for which there are no effective treatments or which have shown resistance to existing drugs. Therefore, research in this field is essential to find effective drugs against the pathologies that affect human beings. In this case, TECH presents a very complete education on Clinical Trial Management and Monitoring for Nursing, since research is a multidisciplinary field that depends on different sectors. 

Research is a field that is growing every day, thanks to the efforts of public bodies and private institutions to invest in this field, achieving the appearance of successful drugs that allow the survival of patients fighting against diseases that until now had no cures or treatments that would allow them to improve their quality of life in the face of chronic illnesses. 

It is a multidisciplinary field in which professionals from different health fields participate. Therefore, in this case, TECH has designed this comprehensive program specifically for nurses, with the aim of acquiring specialized knowledge on Clinical Trials Management and Monitoring for Nursing, through a theoretical and practical education provided by professionals with extensive experience. 

The teaching team of this Professional Master's Degree has made a careful selection of topics, useful for experienced professionals working in the healthcare field. This program specializes the nurse in the field of clinical trials, being able to access the pharmaceutical industry field in the management and monitoring of clinical studies. 

In addition, this program includes the most advanced web 2.0 communication tools, which support working methods that encourage interaction among students, the exchange of information and constant and active participation. 

As it is an online program, the student is not constrained by fixed schedules or the need to move to another physical location, but rather, they can access the contents at any time of the day, allowing them to balance their professional or personal life with their academic life as they please. 

Expand your knowledge through this Professional master’s degree that will allow you to specialize until you achieve excellence in this field"

ThisProfessional master’s degree in MBA in Management and Monitoring of Clinical Trials for Nursing for Nursing contains the most complete and up-to-date scientific program on the market. The most important features include:

• The development of case studies presented by experts in Clinical Trials
• The graphic, schematic, and practical contents with which they are created, provide scientific and practical information on the disciplines that are essential for professional practice
• New developments in Clinical Trials
• Practical exercises where self-assessment can be used to improve learning
• Special emphasis on innovative methodologies in Clinical Trials.
• Theoretical lessons, questions to the expert, debate forums on controversial topics, and individual reflection assignments
• Content that is accessible from any fixed or portable device with an Internet connection

This Professional master’s degree is the best investment you can make when selecting an up-to-date program for two reasons: In addition to updating your knowledge in MBA in Management and Monitoring of Clinical Trials for Nursing, you will obtain a degree from TECH Global University

The teaching staff includes professionals belonging to the field of health, who bring to this program the experience of their work, as well as recognized specialists from reference societies and prestigious universities. 

The multimedia content, developed with the latest educational technology, will provide the professional with situated and contextual learning, i.e., a simulated environment that will provide immersive education programmed to learn in real situations. 

The design of this program is focused on Problem-Based Learning, so the healthcare professional must try to solve the different professional practice situations that arise throughout the academic program. To do so, the professional will be assisted by an innovative interactive video system developed by recognized experts in the field of Clinical Trials Management and Monitoring for Nursing, and with great experience. 

This 100% online MBA will allow you to balance your studies with your professional work while increasing your knowledge in this field"

Do not hesitate to take this educational program with us. You will find the best teaching material with virtual lessons"

TheMBA in Management and Monitoring of Clinical Trials for Nursing for Nursing program is oriented to facilitate the performance of the research professional with the latest advances and most innovative treatments in the sector. 

Thanks to thisProfessional master’s degree you will able to specialize in Clinical Trials Management and Monitoring for Nursing and learn about the latest advances in the field"

General Objectives

• Establish the phases involved in the development of a new drug
• Analyze the steps prior to the development of a clinical trial (preclinical research)
• Examine how a drug is introduced into the market after the clinical trial has been conducted
• Establish the basic structure of a Clinical Trial
• Justify the difference between different types of clinical trials
• Compile the essential documents and procedures within a clinical trial
• Develop the clinical trial drug circuit from the point of view of the pharmacy service
• Analyze universal ethical principles
• Compile the rights and duties of the different parties involved in clinical trials
• Substantiate the concept of monitoring
• Analyze the content of a clinical research protocol and recognize the commitment that a good compliance with it entails
• Master the skills necessary for project development and management
• Define the monitoring process of a clinical trial, having the necessary documentation, tools and guidance for this role, taking into account the main problems that may be encountered
• Present the latest scientific advances in clinical trial monitoring tasks, with knowledge adapted to the real needs of companies in the pharmaceutical sector
• Present the wide range of tasks involved in conducting a CE and what is involved at each stage of the clinical trial
• Explain the practical aspects of conducting a CT and the role of the monitor
• Analyze the importance of the role of the trial coordinator in clinical research
• Specify the main functions of the research team and their involvement with the patient
• Establish the main components of a clinical trial and observational study
• Develop specialized knowledge about the variety of tasks they have to perform during the development of the study
• Establish tools and strategies to address the different problems that arise during the clinical trial, in order to obtain satisfactory results in patient monitoring
• Develop knowledge that provides a basis or opportunity for originality in the development and/or application of ideas, often in a research context
• Apply the acquired knowledge and resolution skills in the development of protocols
• Structure statistical methods and techniques
• Communicate and transmit statistical results through the preparation of different types of reports, using terminology specific to the fields of application
• Compile, identify and select sources of public biomedical information, from international agencies and scientific organizations, on the study and dynamics of populations
• Analyze the scientific method and work on skills in the handling of information sources, bibliography, protocol elaboration and other aspects considered necessary for the design, execution and critical assessment
• Demonstrate logical thinking and structured reasoning in determining the appropriate statistical technique

Specific Objectives

Module 1. Drug research and development

• Explain the pharmacokinetic processes that a drug undergoes in the organism
• Identify the legislation that regulates each of the steps in the development and authorization of a drug
• Define the specific regulation of some drugs (biosimilars, advanced therapies)
• Define the use in special situations and their types
• Examine the process of financing a drug
• Specify strategies for the dissemination of research results
• Present how to read scientific information critically
• Compile sources of information on drugs and their types

Module 2. Clinical Trials I

• Establish the types of clinical trials and standards of good clinical practice
• Specify the processes of authorization and distinction of drugs and medical devices in research
• Analyze the evolutionary process of drug research development
• Specify strategies for developing a safety surveillance plan for marketed drugs
• Substantiate the necessary requirements for the initiation of research with drugs in humans
• Establish the elements of a clinical trial research protocol
• Substantiate the difference between inferiority and non-inferiority clinical trials.
• Compile the essential documents and procedures within a clinical trial
• Specify the utility and learn the use of data collection notebooks (DCNs)
• Disclose the types of fraud committed in clinical trials research

Module 3. Clinical Trials II

• Specify the different activities related to sample management (reception, dispensing, custody, etc.) in which the Pharmacy team is involved
• Establish the procedures and techniques involved in the safe handling of samples during their preparation
• Analyze the development of a clinical trial through the vision and participation of the hospital pharmacist
• Detail informed consent
• Know the physiological differences between children and adults

Module 4. Monitoring of Clinical Trials I

• Specify both the professional profile of the clinical trial monitor and the skills that must be developed to carry out the monitoring process of a clinical trial
• Establish your responsibility in the selection of the center and in the initiation of the study
• Justify the importance of the monitor in ensuring, during the trial, the correct compliance with the procedures and activities established by the protocol and the Good Clinical Practice Guidelines
• Generate knowledge on the practical aspects of visits prior to the start of the clinical trial
• Present the basis for the essential documentation for the implementation of the clinical trial at the center
• Prepare the student in the correct handling of a pre-selection visit and initiation in the research center
• Assess the involvement of the Hospital Pharmacy Service in the management, control and traceability of the medication in the study
• Justify the importance of maintaining good communication between team members involved in the development of a clinical tria

Module 5. Monitoring of Clinical Trials II

• Establish the basic points of a monitoring and closing visit.
• Develop the Monitoring Plan and Standard Operating Procedures (SOP) at each stage of the clinical trial
• Present a data collection notebook and specify how to keep it up-to-date
• Establish the data collection process to assess safety in a clinical trial. Adverse Event and Serious Adverse Event
• Reproduce the management of a monitoring visit
• Analyze the most common protocol deviations
• Establish the important documents for a clinical trial
• Submit a Clinical Trial monitor’s guideline (Monitoring plan)
• Present the data collection notebooks
• Develop important theoretical knowledge about closeout visits.
• Establish the documentation to be prepared for closeout visits.
• Specify the points to be reviewed in the closeout visits.

Module 6. Coordination of Clinical Trials I

• Specify the mandatory documents and forms that must be included in the researcher’s file
• Establish how to best manage the archive at the beginning, during and at the end of the study: storing, updating and ordering documentation
• Define the steps to be followed to complete the documents and forms for the researchers file

Module 7. Coordination of Clinical Trials II

• Substantiate the necessary skills to be developed in order to perform the work of the trial coordinator
• Define the organization and preparation of both the research team and the center for their inclusion in a clinical trial, managing the CV, good clinical practices, suitability of the facilities, etc.
• Reproduce the tasks to be performed in both a clinical trial and an observational study.
• Analyze a clinical trial protocol through theoretical and practical examples.
• Determine the work of a coordinator in their work center under a clinical trial protocol (patients, visits, tests)
• Develop the skills necessary for the use of a data collection notebook: data entry, query resolution and sample processing
• Compile the different types of pharmacological treatments that can be used in a clinical trial (placebo, biological) and their management

Module 8. Follow-up of Patients in Clinical Trials

• Specify the daily practices of patient care in specialized care, establishing the management of clinical trial procedures, protocols and databases
• Analyze the materials used during the development of the studies
• Assess the causes of patient dropout within a study and establish strategies for patient retention
• Assess how monitoring loss occurs in patients within a study, examine its causes and explore possibilities for resumption of monitoring
• Compile the different risk factors that can lead to poor adherence to treatment, and apply strategies for improving and monitoring adherence to treatment
• Analyze the different presentations of medications in order to manage the signs and symptoms, as well as the adverse reactions that may derive from taking medication
• Establish the different tools to calculate the attendance and monitoring of visits

Module 9. Biostatistics

• Identify and incorporate in the advanced mathematical model, which represents the experimental situation, those random factors involved in a high-level biosanitary study
• Design, collect and clean a data set for subsequent statistical analysis
• Identify the appropriate method for determining the sample size
• Distinguish between different types of studies and choose the most appropriate type of design according to the research objective
• Communicate and transmit statistical results correctly, through the preparation of reports
• Acquire an ethical and social commitment

Module 10. Leadership, Ethics and Social Responsibility in Companies

• Analyze the impact of globalization on corporate governance and corporate social responsibility
• Evaluate the importance of effective leadership in the management and success of companies
• Define cross-cultural management strategies and their relevance in diverse business environments
• Develop leadership skills and understand the current challenges faced by leaders
• Determine the principles and practices of business ethics and their application in corporate decision making
• Structure strategies for the implementation and improvement of sustainability and social responsibility in business

Module 11. People and Talent Management

• Determine the relationship between strategic direction and human resources management
• Delve into the competencies necessary for the effective management of human resources by competencies
• Delve into the methodologies for performance evaluation and management
• Integrate innovations in talent management and their impact on employee retention and staff loyalty
• Develop strategies for motivation and development of high performance teams
• Propose effective solutions for change management and conflict resolution in organizations

Module 12. Economic and Financial Management

• Analyze the macroeconomic environment and its influence on the national and international financial system
• Define the information systems and Business Intelligence for financial decision-making
• Differentiate key financial decisions and risk management in financial management
• Evaluate strategies for financial planning and obtain business financing 

Module 13. Commercial and  Strategic Marketing Management

• Structure the conceptual framework and the importance of commercial management in companies
• Delve into the fundamental elements and activities of marketing and their impact on the organization
• Determine the stages of the strategic marketing planning process
• Evaluate strategies to improve corporate communication and the digital reputation of the company 

Module 14. Executive Management 

• Define the concept of General Management and its relevance in business management
• Evaluate the roles and responsibilities of managers in organizational culture
• Analyze the importance of operations management and quality management in the value chain
• Develop interpersonal communication and public speaking skills for the formation of spokespersons

ThisProfessional master’s degree is the best way to get up to standard in the Trauma Nursing"