For professionals working in the clinical research field, the skills required to perform essential duties vary widely from one job to another. However, there are some areas in which everyone should have sufficient knowledge, no matter what position they hold.
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
In his presentation, Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional, Sonstein discussed an effort to align and harmonize 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.
This effort is led by a group known as the Joint Task Force for Clinical Trial Competency (JTFCTC), which is comprised of representatives from AMCs, sites, CROs, sponsors, and professional societies. The JTFCTC developed a list of core competency domains and the cognitive competencies within each domain.
Below are eight key competencies of the clinical research professional as defined by the JTFCTC.
1. Scientific Concepts and Research Design
Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials.
2. Ethical and Participant Safety Considerations
Encompasses care of patients, aspects of human subject protection and safety in the conduct of a clinical trial.
3. Medicines Development and Regulation
Encompasses knowledge of how drugs, devices, and biologics are developed and regulated.
4. Clinical Trial Operations (GCPs)
Encompasses study management and GCP compliance, safety management (adverse event identification and reporting, post market surveillance, and pharmacovigilance), and handling of investigational product.
5. Study and Site Management
Encompasses content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory/GCPs).
6. Data Management and Informatics
Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.
7. Leadership and Professionalism
Encompasses the principles and practice of leadership and professionalism in clinical research.
8. Communication and Teamwork
Encompasses all elements of communication within the site and between the site and sponsor, CRO and regulators, as well as the understanding of teamwork skills necessary for conducting a clinical trial.
It is difficult to generalize skills and qualities that are equally important across all organizations, jobs, and experience levels, but those that can master these competencies will be positioned to succeed in the industry.
If you’re serious about becoming a well-rounded clinical research professional, you need to have a broadened understanding and knowledge of many topics. There are many educational resources and tools that can help you learn about the industry.
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