One of the most challenging jobs or careers in clinical research is the Clinical Research Coordinator or CRC. He plays a vital and specialized role in the clinical research process.
What does a CRC do?
The CRC holds a big responsibility in the clinical research process from the beginning of the study.
- Before the study commences, the CRC must submit to the Institutional Review Board (IRB) and seek for their consent when human subjects will be involved in the study.
- He acts as a liaison between the IRB and the sponsor. When the Informed Consent approval is given, the clinical study can begin.
- He also coordinates with the sponsor, the Principal Investigator and the site where the study will be conducted so they can arrive at a Clinical Trial Agreement (CTA) for all parties to conform to the policies and procedures.
- Cost analysis for the project including miscellaneous expenses to be incurred after thorough review of the protocol schema and in order to evaluate the standards for patient care and/or research.
- He is responsible in the subject recruitment and also must conduct patient care visits to the patients under clinical trials. If any adverse effects have been found in patients, the CRC must note down and report all adverse effects to the sponsor and the IRB. All activities in the course of the study must be documented by the CRC.
In a research team, there would be CRCs assigned to conduct different clinical trials while being supervised and guided by the Principal Investigator. They are responsible in carrying out the daily activities in the clinical project. As a member of the team, he is in charged of the data organization and research connected with the clinical studies.
The responsibilities of a CRC include observation and selection of objects. He also helps in analyzing whatever information has been acquired. As a CRC, he needs to perform many tasks and his creativity, planning and judging skills are always handy!
A good clinical research coordinator should possess the following:
- A strong interpersonal skill
- Good communication skills is a must
- Organizational skills especially in detailing
- Computer literacy
- Proficiency in documentation
- Ability to multitask
- Knowledge of research procedures and regulatory requirements
The task of a CRC is demanding so he needs to possess the skill in managing time. Because he is a well-trained and active professional, his energy level is higher than the rest in performing all their duties.
In clinical researches, the CRC employees are always working with the different areas of studies or specializations. They collect information from various research sites and organizations while assisting the working station or headquarters of CRCs. So you see, the work of a CRC is extremely important in clinical research.