The Multi-Regional Clinical Trials (MRCT) Center co-led an effort in 2013 to convene a group of diverse stakeholders to align and harmonize the many focused statements relating to core competencies for clinical research professionals into a single, high-level set of standards that could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. The MRCT Center is now leading the Joint Task Force (JTF) for Clinical Trials Competency to adapt and evolve the Framework to meet the needs of its stakeholders globally.
The Enhancing Clinical Research Professionals’ Training and Qualifications project adopted the JTF Core Competencies to develop competency standards targeting principal investigators and clinical research coordinators. The resultant competencies “wheel” can be utilized to define professional roles and performance evaluations, to define education and training requirements, professional certification criteria and continuing professional development needs, as well as to facilitate regulatory compliance, quality improvement and financial status of the clinical research process.
The JTF Core Competency Framework identifies the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research. Learn more about the competency domains and statements by clicking here.
Scientific concepts and research design
Ethical and participant safety considerations
Medicines development and regulation
Clinical trial operations
Study and site management
Data management and informatics
Leadership and professionalism
Communication and teamwork