Industry’s best training program for CRAs and clinical trial personnel

For a successful clinical trial, It is essential to understand how crucial it is for every company to have an experienced Clinical Research Associate and Clinical trial personnel.

 

In some countries, where clinical trial and research have just begun to bloom, availability of associates and personnel having appropriate training that fit the specific requirements of the role they will perform in clinical research is critical.

Core knowledge assessment and training of clinical research professionals are yet to be standardised in the clinical research industry. However, there is a general consensus among research professionals that CRAs and CTPs usually perform additional duties for which they are neither adequately trained nor paid. Here, CRAs have roles such as research consultants, protocol trainers, source document verifier, problem anticipators, site auditors, and liaisons between site and sponsor.

Clinical trials are conducted on human subjects in order to analyze investigational drugs, products and therapies that are intended to help future patients. Presently, such tests and investigations are accomplished by researchers and trial personnel who follow detailed protocols that protect subject safety and data integrity. In clinical trials conducted today, roles of research team members have evolved and become specific to such positions such as clinical research associate (CRA), principal investigator (PI), and clinical research coordinator (CRC) on behalf of the sponsor, for any trial, CRA monitors the ongoing progression of clinical investigations from beginning to the end.

A clinical research associate and clinical trial personnel have different roles to play in the industry with varying requirements of skill. Research professionals must respect, uphold and maintain the ethical boundaries that are firm and clear to satisfy the demands of the industry. To manage and comply with regulatory obligations, clinical research professionals must showcase a mastery of their knowledge and continually seek opportunities to add to their education and contribute to the advancement of their position and profession. Even though the two research positions are highly specialised and demonstrative, there are overlapping skills and knowledge required in both.

The training seeks to build skills and knowledge of an individual as well commits to producing excellent products. Training increases the growth of the company and the individual manifolds. Training becomes specifically crucial in a clinical trial due to the safety of human subjects involved in the study and future treatment of patients. Untrained research professionals may be not only harmful to themselves but also to the people and the human subjects they encounter in their daily routine. Effective CRAs consider the ability to anticipate problems and hurdles of clinical trial just as crucial as adequately solving unintended issues once it arises.

Industries nowadays have started to invest a lot in training programs.Before choosing any training program, industries should ensure that their #1 priority should be the trainee as a future CRA or Clinical trial personnel so that they can work harder, better and with more interest for the upcoming research in various fields. Thus the industrial training programs that are held should be able to make them learn about every aspect, not only the knowledge about the topic of research or, but also teamwork, work ethics, and values.

While designing training presentations of SOP for employees, the main challenge was to be creative and effective. With the progression of technology in recent years, new research professionals expect more options in the learning process and try to bring in new ideas and variation in the method of teaching. Trainers find methods to bring relevance and entertaining ways to illustrate all aspects of their presentations in order to get a fruitful result.

The industry’s best training program
  • defines roles and duties of CRAs according to the information reviewed in clinical journals
  • designs and organises SOP training modules through topic associated quizzes and PowerPoint presentations in order to illustrate expectations and measure the effectiveness of the training program.
  • compares the training program used by other industries to commercially avail their programs in order to bring in proper training tools to train clinical research professionals

 

The Training manual demonstrates and differentiates the varying methods and modules utilised to train clinical researchers with a special focus on the positions of Clinical trial personnel and clinical research associates. Employee interviews and questionnaires were given as supplement resources such as clinical research journals and clinical research websites.

During the beginning of the program as known as the implementation and maintenance phase, the training program is conducted and then followed by an analysis of the training program’s effectiveness. During the post analysis, the program’s insufficiency is highlighted through the examining post-surveys and review of trainees. The trainer should understand and be flexible to changes that need to be done in order for the training to be most effective. After the post analysis, future requirements of the training program are evaluated in order to improve cost, efficiency and effectiveness of future training programs.

 

Skill requirements and Knowledge areas required as a CRA AND CTP  are classified into six broad categories
  • General
  • Ethics
  • Teamwork
  • Regulations
  • Clinical trial execution
  • Leadership
  • Negotiation
  • Conflict management
  • Methodology
  • Interpersonal skills
  • Computing
  • Presentation skills
  • Data management and statistics
  • Communication skills

 

Goals to be attained during the span of training can be acquired through questions and answers about the requirements of the training session during the trainers’ meeting. Long- term and short-term goals for the training sessions should also be mentioned and addressed.

Mundane and vigorous training exercises should be minimised, and replaced by specific real-life case activities in order to enhance the critical thought process of the trainee and help them understand real-life situations.

This training program has vision, expertise and commitment towards the services provided and seeks the results to be in a positive outsourcing experience. It ensures delivering a consistent batch to batch reproducibility manufacturing designs and skills required by a CRA and CTP.

 

CTPs are regularly involved in numerous roles at study sites, and at times they have an overbearing amount of responsibilities, while CRAs act as a consultant to sites and sponsors, experts on clinical trials, and mentor the learning process of researchers. The growth of the CRA job market seems to be increasing due to high job satisfaction, high salary, and the personal connection offered in their position. However, it is clear that both the positions require core training in leadership development, excellent communication and research knowledge for successful clinical trials.

 

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