Ebtihal Abdelhay Alsharief

1. Coordinate data and operational compliance activities on project(s) to ensure successful delivery.

2. Ensure accurate and timely entry of all data in the CRF/data collection tool from the source data/ notes, and track the flow of the CRF's, queries, and patient recruitment statuses; reports out the flow of data.

3. Participation in any trainings and meetings related to the specific project.

4. Maintain the ISF, project files, and trackers comply with GDP.

5. Follow regular QC process and checks to ensure project specific files are maintained, reviewed, and assessed within the appropriate timelines and flag any out-of-range values, ensuring audit readiness.

6. Identify QI and report them and apply CAPA reporting and root cause analysis, if applicable.

7. Coordinate the collection, validation, and management of data from sources such as electronic health records (EHRs), registries, claims databases, and patient-reported outcomes.

8. Identify and escalate priority issues pertaining to Pharmacovigilance activities, confirming, recording, and reporting of Adverse Events.

9. Prepare for and take part in audits and inspections.

10. Interpret and adhere to company SOPs and policies and assist with input during the review process.

11. Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patient admission processes in coordination with the researchers; planning and taking the necessary precaution when required

• Act as a core study compliance lead on several studies to ensure the successful delivery of projects
• Main Contact between site staff and clinical operations
• Highlight any auditor findings and proposes CAPA actions
• Participate in the start-up, set-up, conduct and close out of studies, ensuring adherence to the clientʼs expectations
• Identify quality issues (QI) and reports on it and support and mentoring junior CSCs in this process
• Work and handle with the source documents, other essential documents as delegated by the PI tasks and activities to the extent of their qualification, experience and under supervision of qualified site personnel, if needed
• Ensure accurate and timely entry of all data in the CRF from the source data/ notes and tracks the flow of the CRFʼs, queries and patient recruitment status and report out the flow of data
• Participation in any trainings and meetings (incl
• Investigator Meetings) related to the specific study
• Receive IP shipments and handle it on the site

• Patient educator for Thalathemia patients
• Drug reporter for any adverse events from (Exjude, Desferal and Jadenu)
• Coordinating educational programs for groups of patients who are undergoing similar treatment plans
• Delivering relevant information to patients in a manner that is easy to understand
• Conducting one-on-one sessions with patients in order to educate them about their condition, treatment plan, and self-care instructions
• Serve as an ongoing resource for Thalathemia patients
• Designing and delivering educational programs on a variety of topics including nutrition, exercise, stress management and medication use