What are 8 aspects of a good clinical research and development staff?

the | The author is a doctor and a senior physician with nearly 20 years of industry experience.
are happy to share the progress of the clinical research and development industry and foreign experience.
welcome to ask questions interactively.
---------- The modern pharmaceutical industry has made tremendous progress since 1910, when Paul Ehrlich and his Japanese assistant, Qin Sasaki, discovered the arsenic vanamine (compound No. 606, diazepb arsenic benzene) for syphilis.
clinical development has grown rapidly over the past 20 years, with more and more new drugs and treatments clinically proven to be approved for market.
is accompanied by continuous updating of technology, continuous refinement of regulations, clinical research to carry out gradual digitization, corresponding to the division of labor among clinical research and development practitioners has also evolved.
industry as a whole on the clinical research and development personnel's knowledge structure, technical ability and team coordination and other hard and soft professional ability requirements are also rising.
the needs of the industry is a huge challenge to the existing education and training system.
resulting in the recruitment of enterprise personnel and staff retention can not meet their own development needs, the professional development of practitioners themselves, training needs and competency assessment is not rule-based, can not complete their work well.
foreign counterparts have been committed to solving this problem, and strive to professionalize clinical research and development practitioners, that is, with a good knowledge structure, practical technology, first-hand experience and the ability to adapt to the needs of the industry to improve and improve.
for professionalization, foreign counterparts use the term "competencies" to describe the ability to successfully apply knowledge and abilities to their daily work.
foreign counterparts believe that past work experience is not equal to professional ability, vocational ability should include at least the following dimensions: knowledge, skills and abilities, work attitude and job performance.
the professional ability itself can not be fully achieved through theoretical education, but need to be continuously improved in the work.
generally believe that a colleague now has a certain professional ability valid for 2-3 years.
is the so-called "master led into the door, practice in the individual."
currently, the World Health Organization (WHO), the Association of Clinical Research Professionals (ACRP) and harvard University's Multi-Regional Clinical Research Center lead Clinical Trial Capabilities Partnership (JTF) are the organizations that conduct in-depth research on the description of professional competency.
a number of regional non-profit sub-professional associations have also done a lot of work.
the capability framework proposed by JTF has gradually gained the approval of most of its peers in the industry, and its influence has gradually increased.
JTF capability framework consists of 8 domains and 48 core competency.
has released version 3.1.
8 areas are: 1. Mastering the scientific concepts related to clinical trial design and analysis.
2. Master the protection and safety of subjects in clinical trials.
3. Master drug development processes and regulations.
. Master the management of clinical research.
. Mastering the management of research centres.
6. Master research data and information management.
7. Have the leadership and professionalization required for clinical research.
8. Have the ability to communicate and team work.
more important than describing your professional abilities, is how to assess the abilities of your industry colleagues.
JTF uses a level 3 assessment criteria, which are (1) primary: you can work and/or have the knowledge and ability you need to do so, requiring some coaching.
(2) skilled: can work independently, the results of the work consistent and accurate, with a medium level of technology.
work is efficient and the results are of high quality.
can independently find resources and use tools appropriately.
(3) experts: demonstrate advanced skills and knowledge to train, coach and mentor other colleagues.
can think critically and solve problems.
Other peers have also proposed level 4 assessment methods: level 1: novies, need help and guidance; level 2: beginner, need guidance; level 3: intermediate, able to work autonomously, require less guidance; level 4: experts, support, training and mentoring.
The professional (team) JTF clinical trial capability framework in drug research and development is well-established, and the description of pro-research vocational competence helps the industry to carry out training needs assessment, training and vocational education design, job responsibility development, researcher selection, research center selection and quality assurance.
The stone of the mountain, can attack jade, I believe that the domestic same way can refer to reference, develop and improve suitable for China's pro-research professional ability and evaluation system, to help new drug research and development, benefit more patients.
References: 1.