nih research training

ICH GCP Certification

ICH is the abbreviation for International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. The ICH is an international body that sets the standard which becomes regulations for clinical trials involving human subjects. The ICH sets the standard that defines the guidelines for Good Clinical Practice (GCP).

GCP is an international standard that ensures that ethical and scientific qualities are maintained in the designing, recording and reporting of clinical trials involving human subjects.

The aim of this regulatory standard is to ensure that the well-being, right and safety of the human beings recruited for clinical trials are protected. It also aims to ensure that data gotten from clinical trials are accurate, reliable and credible, irrespective of wherever or whatever clinical research facility that the trials are being conducted in the world.

ICH GCP certification is a formal recognition of an individual's knowledge and competence in their ability to carry out applicable GCP guidelines under different circumstances.

It is important for all professionals in the clinical research industry to get the much needed training in Good Clinical Practice (GCP) and be certified as well. As a matter of fact, most companies now take measures to ensure that their staff are GCP certified. Being GCP certified has become a minimum requirement for anyone who would like to explore a career in the area of clinical research.

Although all clinical research professionals are required to be GCP certified, GCP certification is of more importance to the following individuals:

It is highly recommended all over the world to get the Good Clinical practice (GCP) training and certification if you are a clinical research professional or you are aspiring to be one. That is the least acceptable standard to work in the clinical research industry. Beyond GCP certification being a required minimum for a clinical research professional. There are a few other reasons why you need the GCP certification. They include:

  • It is a global formal acknowledgement of an individual's professional eligibility to work as a clinical research professional.

  • In order for organizations involved in the business of clinical research to comply with the laid down industry guidelines and regulations, Good Clinical Practice (GCP) training is important for members.

  • GCP training equips the participants with the knowledge of the regulations that are applicable in clinical research.

  • Pharmaceutical and biotech companies, as well as contract research organizations recommend that their employees are GCP certified.

ICH GCP in today's clinical research world is now more important than ever. The evolution of medical science and the complexities of research process highlight the importance of guidelines that ensure that clinical research are carried out properly.

Clinical Research Associate Training and Placement.

The role of the clinical research associate is very important in clinical trials to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. You may also discover the availability of associate degree programs depending on the school. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for an online program, different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as with the lecturers. Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields like medical assistants, nurses etc, and are interested in moving to the field of clinical research. They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials. During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective, the need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience of clinical trials. Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to. Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might get more chance with that.

Good luck as you take the bold steps.

Clinical Trial Assistant Training

The work of a clinical trial assistant in the set up of a clinical research can never be overstated. It is an important job that requires a whole lot of interest in order to be successful as one. If you have developed interest in becoming a clinical trial assistant, there are certain questions that you must ask yourself. Are you really cut out for this career path? Can you ensure that your availability during the duration of a research from start till its completion, to monitor the trial subject and ensure that the trial is conducted in a safe and ethical manner? Are you eager to take up more responsibilities in a work place? If your answers to this questions are yes, then you might just be cut out for the job of a clinical trial assistant.

A clinical trial assistant or clinical research associate have a lot of responsibilities and roles to fulfil within a clinical research institute to ensure the success of a clinical research. Some of these responsibilities include:

  • They are responsible for maintaining the standard operating procedures (SOP).

  • It is their duty to provide regular report updates of the progress of clinical studies to the appropriate personnel.

  • They are involved in the planning and conducting of pre-study site evaluation.

  • They conduct clinical site feasibility and are as well involved in study visibility.

  • They assess the study subjects to ensure that the appropriate clinical protocols are observed and the trial is in sync with laid down regulations.

The minimum educational requirement for an entry level job as a clinical research associate is an undergraduate degree in health sciences related courses like nursing, life sciences, medical science, biotechnology etc. A diploma in clinical research from a reputable clinical research institution is also another way to go. But graduate degrees offer more benefits and opportunities like a higher pay, eligibility for senior positions etc.

Another avenue through which you can become a clinical trial assistant is through the administrative side. This is possible and is most common for people without formal education in the fields mentioned. It is however a tasking work and very demanding as it requires a lot of administrative knowledge in the area of clinical research.

To be successful as a clinical research associate, there are certain skill sets that are required.

  • A knowledge of the challenges and restrictions involved in the implementation and retention of databases.

  • A complete understanding of the responsibilities and liabilities involved in the use of humans for trial tests.

  • An ability to make excellent clinical development plan.

  • Must be able to ensure that data gotten from clinical trials are accurate and reliable and the legal rights and privacy of the subjects are protected.

Having these above listed skills and being efficient in them make the job of a clinical trial assistant easier and more interesting.

Clinical research associates can work in several kind of organizations including:

  • Clinical research organizations (CRO)

  • Pharmaceutical companies

  • Biotechnology companies etc.

Becoming a clinical trial assistant does not require much. If you're interested, get a degree in the required field and then apply afterwards to increase your chance of success.

Clinical Research Training for Nurses

Clinical research nursing is nursing practice with a specialty focus on the care of research participants in which nursing care delivery parallels. They are responsible for designing and implementing research studies. To know about this post visit us now!

Clinical Research Assistant

Get the right clinical research assistant job from CCRPS, Here you can get the all information about clinical research assistant job post. To know more visit us now!

Clinical Research Books

With more scientific discoveries and technological advancements comes new knowledge. This knowledge redefines the scope and practices of the different fields of professions that they apply to. Medical science is not left behind in these technological advancements and due to the ever continuous nature of medical research, it means medical science is not also left behind in scientific discoveries. This means that more often than not, there is a new knowledge, a new way of doing something. It could be something as routine as checking the blood pressure of a patient or even measuring the body temperature more accurately. A clinical research scientist knows that they have their work cut out, to ensure that they stay up to date with scientific discoveries and new knowledge which can help them in their own research as well.

If you have been offered a clinical research job or you are interested in one, one thing you should know for sure is that to be successful in this field, you need to be knowledgeable. It is true what they say, to remain relevant in any field is to remain knowledgeable.

To help your cause, we have made a list of books that will help you to be relevant in the clinical research field.

  • Fundamentals of Clinical Trials, by Lawrence M. Friedman, Curt D. Furberg, David DeMets. This book looks into key issues like assessment, reporting of results, randomization, interpretation etc. This book introduces clinical trials to you beautifully, with real life examples used to explain key features of clinical trial.

  • Designing Clinical Research, by Dr. Stephen B Hulley, MD, MPH, Steven R Cummings, MD, Warren S Browner, MD. This book is a very important book for doctors, pharmacists, nurses and other medical professionals involved in medical research. It explains useful methods for designing, funding and implementing clinical research.

  • Publishing and Presenting Clinical Research, Third Edition, by Warren S. Browner MD. This book explains the essentials of clinical trials and publishing them to. This book will come in handy for investigators who wants to know more about organizing, delivering and publishing the results of their research in the best way possible.

  • Practical Guide to Clinical Data Management, Third Edition, by Susanne Prokscha. One issue that always pops up in clinical research is that of managing the large volumes of ever increasing data. This is a task that has been rightfully tagged time taking. This book however gives powerful insights on current industry tactics and the use of Electronic Data Capture (EDC) for clinical research. This book will help solve the age-long problem of managing voluminous clinical research data.

Other books

Basic principles of clinical research and methodology by S. K. Gupta

A clinical trial manual from the duke clinical research institute. Kate Davis, Margaret Liu.

Handbook for good clinical research practice. WHO.