Fida Jreij Chehade Email & Phone Number

Lebanon

• Accountable for the day-to-day planning, execution and reporting of clinical studies, including study feasibility and close out.
• Ensures that study start-up activities are conducted and completed on time. This includes the preparation of IRB/EC submission packages, the review of Informed Consent forms and the forecast of comparator needs as.
• Managed Studies budget, negotiated agreements and ensured payments are processed in timely manner.
• Set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.
• Ensuring compliance with the regulatory requirements, the international guidelines and the company policies and standard operating procedures.
• Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation/resolution.

• Selection, initiation, monitoring and close out of investigational sites in accordance with ICH GCP guidelines.
• Identifying potential risks to study timelines, budgets and data quality. Developing and implementing risk mitigation plans.
• Perform on-site monitoring activities (drive patient recruitment, source data verification, provide guidance and resolve issues).
• Management of study treatments: drug inventory and accountability, declaration of temperature excursions...
• Coordination of the monitoring activities (study progress follow up, planning, objectives) in accordance with applicable SOPs and regulations.
• Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.

• Monitor the conduct of clinical trials, especially enrollment and quality of data.
• Perform monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV trials.
• Responsible to deliver data within timelines and required quality standard and for adherence to monitoring procedures in accordance with ICH-GCP, local regulations and SOPs.
• Supporting audit preparations (all readiness activities and corrective action plans).

Worked as lab technician across different departments (Biochemistry, Hematology, Immunohematology, Parasitology, Bacteriology, Serology, Hemoglobin and protein Electrophoresis).

Bachelor Of Science (Bs), Clinical/Medical Laboratory Science

Lebanese Bachalorea, Life Sciences