Farah Abdel-Ghany

Clinical Research Associate (Site Manager)Full Time

• Job Details:Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., ICH-GCP guidelines in the EMEA Countries including Saudi Arabia (KSA) and Jordan. Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Collaborate and liaise with study team members for project execution. Accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Clinical Trials AssistantFull Time

• Job Details:Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. Helped in developing the strategies of work within the team and training the team members. Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.