Clinical Research Coordinator
by attiya waqqas
1. Sponsor
1.1. Sponsor-written (Email, forms and applications) and verbal (meetings, telephone conversations and perhaps conflict resolutions).
1.2. An individual, organization or company that has taken the responsibility to finance the study. The sponsors usually request the CRCs or CRAs to provide the information based on the patient pool and the availability of the facilities to conduct a clinical trial. CRC is the key contact between the clinical trial site and the sponsor.
2. Institution
2.1. Clinical trial site-Mostly written (forms and applications) and verbal (meetings)
2.2. CRCs or CRAs will be responsible for conducting the appropriate institutional logistics with regards to a clinical trial study. These interactions may involve meetings with the institution's REB board and ensuring the study meets the institution's clinical research policies.
3. Sub-investigators/other clinics
3.1. Other personnel involved in the clinical trial-Mostly written (CRCs send information to clinics and Sub-investigators via emails and information packages). Verbal communication entails providing trial protocol training to clinics and personnel involved with patient care. May also entail some problem solving skills.
3.2. CRCs and CRAs are the essential point of contact to ensure smooth flow of information between the departments that might be involved with the patient care and are aware of the patient's participation in the trial. Sub-investigators are the personnel who have agreed to examine the clinical trial alongside the principle investigator. These could be doctors involved directly with patient care or scientists who share similar interests as the PI and are working on the trial together.
4. Principle Investigator
4.1. Conducts the study-Verbal-meetings, daily study related interactions and phone conversations. Written comprises of emails, study documents, consents and study results. Finally, attention to non verbal cues such as: eye contact and tone are all key forms of communication with the PI.
4.2. May request appropriate study related documentation i.e. consent forms, REB forms. May ask to create study related documentation such as: study related information package for the participants; including but not limited to benefits and risks of the study. May request regular meetings to discuss the trial's progress. Finally, study findings will be presented to the PI in an appropriate document.
5. Patients
5.1. Participants of the study-Verbal and written are primary forms of communications. Non verbal such as tone, eye contact and problem solving abilities are also necessary. Emotional awareness is also necessary.
5.1.1. CRCs inform the patients about the study's benefits and risks. Inform the patients of the essential contacts during the study such as; the principle investigators, nurses and or any other personnel. Occasionally the coordinators will collect patient samples, consents and conduct patient surveys in order to determine the effects of the intervention being tested. CRCs/CRAs will be first point of contact for many study related questions patients might have. Finally, having emotional awareness about the patient, assures the CRCs that the patient is comfortable with enrolling themselves in the study.