Clinical Research Coordinator
by Sara Newton
1. Research Ethics Board
1.1. Verbal: - Interactions will occur during conduction of site inspections along with the site staff - Provide ethical considerations via the investigator Written: - Evaluate proposed research study plan and ensure ethical applicability and relay information to investigator - Provide written approval of clinical research study - Promptly report risks or adverse events that occur during trial Other: - Maintain eye contact to demonstrate confidence - Use positive facial expressions to gain confidence from the REB
2. Principal Investigator
2.1. Verbal and Written: - Communicate all concerns with the study - Be given information regarding the clinical trial, including length, treatment being investigated, dosage requirements, other staff requirements and consent information - Receive information regarding potential adverse reactions that may occur Written: - Provide data from study for analysis (usually via statisticians) - Provide information regarding safety standards and any adverse effects recorded - Request clear, concise information regarding the trial and the drug for complete clarity Other: - Show confidence; Body language is crucial to showing confidence and developing trust of the patients and other researchers involved during the study, in addition to the primary investigator - Maintain professional appearance and demeanor when addressing investigator
3. Research Nurse(s)
3.1. Verbal: - Provide information regarding treatment for patients, in addition to dosage amounts, schedules and other important information regarding administration of product Written: - Provide notes of dosage intervals, amounts and times Other: - Maintain an professional appearance - Maintain a friendly demeanor with nurses - Avoid body language that may suggest unapproachability or negativity
4. Research Pharmacist
4.1. Verbal and Written: - Receive data regarding drug dosage and administration and assess the data alongside the investigator - Ensure complete clarity when discussing dosage requirements - Monitor patterns from trial data regarding the drug and provide this data to the research pharmacist Other: - Maintain professional body language - Maintain eye contact with research pharmacist to show understanding of requirements
5. Patients (or Legal Guardian of Patient)
5.1. Verbal: - Greet patients - Discuss potential adverse effects of drug being taken - Discuss effects of drug on behaviour or any physical effects Other: - Provide friendly support to the patients throughout the trial to ease anxiety - Ensure professionalism while maintaining agreeableness to ensure patients develop trust - Maintain an appropriate level of personal - Monitor body language of patients, for instance a patient in discomfort will show certain facial expressions or positioning that will signal a potential drug side effect. - Monitor behaviour changes to determine if the patients are experiencing behavioural side effects
6. Study Sponsor
6.1. Verbal and Written: - The study sponsor will communicate by on-site visits, in meetings, over the phone or e-mail to determine whether the trial is being appropriately conducting - E-mail communication allows the study sponsor to maintain reports of the clinical trial with the investigator and staff - The study sponsor must review safety considerations and other drug information and relay the information Other: - Ensure professional appearance - Use appropriate eye contact and facial expressions to create trust with the study sponsor - Show confidence in product being investigated
7. Statistician
7.1. Verbal: - Communicate with investigator and staff to retrieve data for analysis - Request clarification of data when required Written: - Provide data to the statistician from the clinical trial for analysis - Provide clarification of details when required Other: - Maintain a professional appearance and demeanor during interactions
8. Clinical Trial Associate(s)
8.1. Verbal: - Request administrative support, e.g. interviewing patients, scheduling patients via phone call or in-person Written: - Retrieve meeting minutes - Interact during meetings by collecting administrative information from the associate - Provide tasks Other: - Maintain a professional demeanor - Maintain eye contact when communicating to allow the associate to develop a proper understanding of the tasks
9. Medical Science Liaison
9.1. Verbal and Written: - Promote the clinical trial by emphasising the merits of the investigational drug. This can be done through verbal communication with research groups or through visual advertising Other: - Use persuasive communication, for instance using plenty of eye contact and correct posture can exude confidence in abilities of the drug