Clinical Research Associate (CRA)

1. Regulatory Affairs Associate

1.1. Work to determine and complete required regulatory documentation. -Individual and group meetings. -Communication via e-mails.

2. Biostatistician

2.1. Conduct statistical analysis during the course of the study to determine if study should be abandoned. -Communicate via the numbers presented and the associated analytical report.

3. Data Safety Monitoring Board

3.1. Provide recommendation for or against continuance of study. -Communicate via the data reports filed to them and the reports they provide upon analysis.

4. Medical Writer

4.1. Work to identify and prepare the various documents related to the study. This may include consent forms and advertising material. -Communicate through artistic expression of various drafts of material produced. -Communicate via e-mail and in-person to finalize the materials.

5. Study Sponsor

5.1. Keep the sponsor updated to ensure proper financing throughout the trial. -Communicate to the sponsor via the investigator through regular in-person meetings.

6. Study Participants

6.1. Explain the study, its requirements, and answer the questions of the participants. Be involved in the process of recruiting participants for the study. -Communicate via e-mail and phone to schedule appointments. -In-person meetings for question-answer sessions, eligibility criteria, etc. -Communicate by providing published work to the participant for their knowledge.

7. Clinical Research Coordinator

7.1. Work under the supervision of Clinical Research Coordinator to carry out the wide-ranging tasks of the clinical study from Research Ethics Board (REB) submissions to monitoring to ensuring consent forms are completed. -Communicate via group meetings, e-mails, and by providing updates on the aforementioned tasks.

8. Investigator

8.1. Coordinate the day-to-day operations to ensure optimal operation of study. -Communicate in-person and via e-mail. -Presentations in group meetings. -Communicate with good performance and organization in study.

9. Clinical Research Assistant

9.1. Perform a variety of administrative tasks as required by the clinical research team. -Communicate via group meetings and e-mails.

10. Nurse

10.1. Administer the study drug and perform any required assessments (blood tests). -Communicate via administering the required tests and accurate study drugs.

11. Research Pharmacist

11.1. Manage the drugs being tested in the study. Ensure that groups receive the correct drug based on their assigned group. -Communicate via ensuring that pharmacist have adequate inventory for the trial and participants receive the accurate drug and dose.