Clinical research Associate
A clinical research associate helps with the processes and execution of clinical trials of new pharmaceuticals, medical devices or treatment practices. A clinical research associate comes from several kinds of backgrounds, with certificates or degrees in such various subjects including business administration, statistics and teaching, but they generally have a degree in one of the life sciences.
Training Information for Clinical Research Associates
The training program of clinical research associates was once handled on site and on-the-job under the administration of the physician or scientist spearheading a clinical study. Certificate and associate’s degree programs have developed to offer validity of consistency to the skill set of acquired by associates. MITS’ training courses may include data collection, management and reporting, clinical research terminology, federal laws and regulations, research protocols, research site management and professional ethics. Participants will also be exposed in actual research studies through supervised fieldwork courses.
Duties and Skills
There are a number of duties incorporated to being a Clinical research associate. Such duties may be learned, acquired, and improved through rigorous training. Some of the many duties as an associate may include the following:
- Preparing a test area
- Preparing and breaking down equipment
- Recruiting and enrolling test subjects in clinical trials
- Interpreting testing procedures to subjects
- Managing and directing experimental medications
- Controlling and documenting the responses of subjects
- Writing progress reports
- Interacting with institutional review boards and government inspectors to ensure compliance to regulations
The Clinical Research Associate (CRA) program, offered by Management & Information Technology Solutions, is designed to develop the needed concepts, skills, techniques, attitudes and knowledge required to execute clinical trials.
A CRA is an individual who functions in varied ways – as an administrator, coordinator, consultant, educator, and/or researcher in the management and control of clinical trials. A CRA will acquire skills in the management and progress of a clinical trial while understanding and meeting both ethical and legal ramifications for all participants. This would include protocol development, data collection, analysis, monitoring, recording, auditing, ethics and regulations, liabilities and responsibilities of conducting research with human subjects.
At the end of this CRA training program, participants will be able to develop the following abilities:
- Gain working knowledge on the healthcare system, associated legislation protocols, procedures and practices for administering the development of healthcare products
- Be able to develop critical reasoning in handling journal article and rate the evidence level
- Be able to design a clinical development scheme, ensuring that clinical trial data is dependable and accurate and the rights, integrity and confidentiality of trial subjects are secured
- Develop a working knowledge on the many challenges and limitations associated in implementing and maintaining databases
Overview of Learning Activities
This course is designed to offer participants with comprehensive coverage of the various topic areas. MITS’ course program will thoroughly provide the nuclear details around which the topics will be covered. We deliver a student centered approach in this coursework to provide better guidance and more effective adoption to the information presented. This course is handled by our expert instructor, coupled with engaging texts, hands-on exercises and real work situations.
Overview of Learning Resources
In this coursework, learning resources include the use of recommended text books, lecture notes (as presented through PowerPoint presentations), handouts or references on selected topics.
Topics covered in this program are as follows:
- Ethical Issues in Human Subjects Research
- Roles and Responsibilities of the Investigator
- Roles and Responsibilities of the Institution
- Regulatory Issues
- Clinical Investigators and the Mass Media
WHO NEEDS TO TAKE THIS COURSE:
This course program is a good choice for individuals who want to tap on clinical and research managements, most especially to professionals from a variety of academic backgrounds, including health sciences, medicine, nursing, health informatics, or epidemiology.