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.• Develops and implements enrollment and recruitment strategies.• Reviews monitoring visit reports and tracks resolution of action items.• Identifies noncompliance and implements preventative and corrective actions.

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 visit reports and follow-up letters includes summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.• 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.• Reviewed Investigator Site Files (ISFs) to ensure essential documents are current and submitted to the Trial Master File (TMF) throughout the trial for ISF/TMF reconciliation purposes. Ensured sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. ISF/TMF must be maintained in an inspection ready state at all times.• Established regular lines of communication and administer ongoing protocol/study-related training to assigned sites. Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site's patient recruitment/retention success and offer suggestions for improvement.

• Assisted with Administration of clinical research projects: site and investigator recruitment, collecting investigator documentation, site management, site monitoring, preparing, and maintaining proper status reports of activities at investigative sites through the duration of a clinical trial and completing other technical tasks to completion.• 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.• Monitored Case Report Forms (CRF) for missing implausible data. Assess compliance with investigational product handling procedures.• Ensured that all adverse events are collected pursuant to GCP.• Reported, write narratives and followed-up on reported serious adverse experiences.• Assisted with generation and reconciliation of queries to investigation sites to resolve problem data.• Assisted and managed project budget and investigator site budget as needed, attend project team meetings, plan, attend and participate in investigator meetings, and communicate with clients.• Generated and tracked investigational product shipments and storage.• Provided coverage to clinical contact telephone lines.• Provided answers to common protocol related questions under the supervision of the Project Manager and Medical Director.

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.• Provided education to patients, families and clinic staff regarding research protocol and investigational agents.• Responsible for the comprehensive management of clinical trials conducted at UT Southwestern, including entering all orders in EMR for all research specific visits and procedures.• Met with patient for each visit and maintained accessibility to discuss any questions/concerns regarding study participation.• Dispensed study medication in a professional and accountable manner following protocol guidelines, patient diaries, where applicable.• Collected, processed and shipped blood/urine specimens at scheduled patient visits.• Performed ECGs and administer questionnaires.• Ensured that serious and non-serious adverse events were properly documented and reported per protocol/institutional guidelines.• Submitted patient reimbursement requests to Clinical Research Manager.• Attended Investigator Meetings and Protocol Specific Training Webinars/Meetings.