Funsho Fadi Email & Phone Number

Morrisville, NC, US

• Communicates with investigators, colleagues, and vendors ensuring clinical quality and compliance.
• Provides oversight of sites and mentorship to junior team members.
• Supports various phases of clinical studies (i.e., study planning, site qualification and investigator selection, monitoring, closeout, etc.).
• Oversees contract research organization personnel site activities and vendor performance.
• Supports the development of clinical study plans, presentations, study documents, contracts, development, and design of case report forms.
• Leads review of clinical data listings for accuracy and escalates issues to the clinical project manager.

Morrisville, NC, US

• Interacted with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials.
• Performed protocol/site feasibility and Pre-Study Visits to recommend qualified sites.
• Participated in Investigator Meetings, CRA and Study Coordinator training sessions, and assist sites with study-related questions as needed.
• Performed Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
• Submitted quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS). Completion of monitoring.
• Assisted with precept/oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their manager/Associate Director.

• Assisted with Administration of clinical research projects: site and investigator recruitment, collecting investigator documentation, site management, site monitoring, preparing, and maintaining proper status reports.
• Qualified, initiated, monitored and closed-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.
• Assisted and managed training of new Clinical Research Associates.
• Provided ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human and or animal subjects.
• Ensured subject safety through diligent monitoring of the site's compliance with study protocols and the collection of adverse event information.
• Updated, tracked and maintained study specific trial management tools/system.

Dallas, Texas, US

• Adhered to Research SOPs.
• Adhered to Good Clinical Practices and the study protocols.
• Coordinated all research activities of the patient, providing assistance, direction, and information as necessary.
• Completed and maintained case report forms per FDA guidelines and reviewed them against the patient's medical record for completeness, accuracy, and legibility.
• Worked closely with physicians, nurses, and other health care professionals to identify patients for clinical trials. Assisted with the recruitment and screening of participants according to protocol requirements.
• Ensured the accurate transcription of trial data.