Who is a Clinical Research Coordinator and what are his/her responsibilities?

A CRC or a clinical research coordinator is a person who has the responsibility of carrying out clinical

trials by the application of the best clinical practice. This is usually done under the sponsorship of a PI or

principal investigator.

Clinical practices can be defined as:

 Trials conducted in an ethical manner

 The patients’ wellbeing, safety, and rights prevail not science

 All the clinical and non-local information to support such a trial based on how it is designed.

 The benefits should outweigh the trials for every patient

 All the trials need to be sound, scientifically speaking and should be described in a clear manner

 All care and decisions to be the responsibility of professionals who are qualified in their specific

fields such as dentists and physicians

 All persons involved in the trials qualified by way of experience, education, and training

 Consent that is informed given by participants feely

 All documentation for the study recorded, then handled and finally stored so as to make it

possible to report, interpret, and then verify

 Subjects’ confidentiality is protected and respected

 The products used to do the investigation maintain best manufacturing practices in handling,

manufacture and storage

 Good systems to make sure that there are high standard

The responsibilities of the clinical research coordinator

The PI is usually responsible for handling the trial. However, it is the CRCs who have the essential duties

like conducting the consent process. They also ensure that all protocols are complied with.

It is the primary responsibility of the clinical research coordinator to protect all human subjects. The CRC

has other responsibilities. They include:

 Budget negotiation with sponsors

 Cost analysis development

 Contract negotiations together with institutional official

 Writing consent documents that are well informed

 Preparation of the IRB submission (institutional review board)

 Submitting data such as CRFs to sponsors

 Preparation of the CRF (case report form)

 Reporting adverse events

 Caring for patients

 Recruiting the subjects

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