1.1. Helps the clinical research team and usually has administrative tasks
1.2. Written and Verbal communication
2. Research Pharmacist
2.1. Written and Verbal communication
2.2. Responsible for managing the study drug and has to make sure the correct drug is given to the correct participant in blind studies.
3. Clinical Research Associate (CRA)
3.1. Written and Verbal communication
3.2. Responsibilities include, making sure study site is ready for the clinical trial to take place, visiting the sites, meeting with investigator and CRC and completing regulatory documentation.
4. Investigator
4.1. Responsible for conduct of the clinical trial at the study site, monitoring the participants and is also the leader of the clinical research team
4.2. Written and Verbal communication
5. Study Manager
5.1. Responsible for overseeing the trial and helping with trouble shooting any issues that may occur during the trial.
5.2. Written communication
6. Safety Associates
6.1. Responsible for reviewing safety data, including reporting any adverse events reported on participants taking part in the trial
6.2. Verbal and written communication
7. Nurses
7.1. Provide and schedule assessments on subjects and also administer study drug. Needs to collect samples and also record important details like start and stop times.
7.2. Written and Verbal communication
8. Data Manager
8.1. Collects the data needed for the clinical trial, including collecting data from medical records. Also needs to be aware of deadlines and address queries coming from study sponsor.
8.2. Written and Verbal communication
9. Research Ethics Board
9.1. Written communication
9.2. REB reviews protocol and all documents that will be given to the patients (ex. consent forms) and reviews product information regarding study drug.
10. Study Participants
10.1. Written and Verbal communication
10.2. Individuals who fit the eligibility criteria and have volunteered to participate in the study
11. Regulatory Authorities
11.1. Regulatory bodies such as Health Canada or FDA, who have an associate that provides support to the clinical trial and who makes sure that the right documentation is available and collected from each study site.
