Eman Badawy Amer

Clinical Research AssociateFull Time

• Job Details:A. Protocol development, administration and follow up: 1. Assisting the study team with the development of clinical protocols, case report forms and reports. 2.Coordinating the protocol review and approval process that includes submissions to top management, SMAC and IRB. 3. Help the team leader in informing the concerned healthcare staff members on the clinical protocol progress and amendments. 4. Archiving study protocol documentation. B. Data Management: 1. The CRS will be responsible of the completed CRFs in collaboration with team Leader and study team. 2. Establishing the protocol’s electronic database in coordination with the data management unit in research department. 3. Monitoring the standard treatment protocols and reports the violations to the study team leader in order to taking an appropriate corrective action. Severe violations should be raised to the patient safety committee. 4. Reporting the results of the protocols to Team Leader and the whole study team every 6 months to be discussed. 5. Archiving documentation and database. C. Combined clinics: 1. Revising the combined clinic list before each combined clinic. 2. Attending the combined clinic. 3. Archiving and following up the decisions taken. D. Educational activities: 1. Help the team leader in informing staff on protocol, practice guidelines & regulatory requirements. 2. Provide new publications and guidelines related to the protocol up on request. 3. Giving lectures regarding the clinical protocol and the specific disease and precautions every unit has. E. Outreach: 1. External consultation and communication with other hospitals/centers regarding cases. 2. Attending experts' visits, taking minutes, preparing reports for the visits and communicate the reports and minutes with the study team.