Ayodeji S, M.S

Site management oversight from start-up (SQVs) to SIVs, vendor access, site staffs’ trainings, IMVs, randomization and tracking of each site status up until study COVs. Maintain paper and electronic Trial Master Files, as well as a Clinical Trial Management System to ensure inspection readiness. Managed study-related documents e.g. informed consent forms, CRFs, site training materials, clinical reports, protocols, etc.

Responsible for assuring and documenting regulatory compliance of study centers through site visits including qualification, initiation, interim monitoring and close-out visits. Assist in the preparation of regulatory submissions (e.g. investigational device exemption applications, institutional review board initial/continuing review). CTA negotiation and amendments, quarterly site payments, etc.

Performed all monitoring visits (SIVs, SQVs, IMVs, COVs) and all other administrative closeout procedures such as IRB termination, databased lock, CRF signoffs by PI, final payments invoices, etc. Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc. Participated and provide support to cross functional teams in the development of study level plans such as data management plan (DMP), CRF, monitoring plans and ensures all EDC are updated with completed visits during Interim Analysis review.

Performed site selection, initiation (SIV/SQV), interim monitoring (IMV), and close-out visits (COV). Conduct Performs IP accountability, ISF review/reconciliation, SDVs and SDRs. Assess factors that might affect subject’s safety and clinical data integrity at site such as protocol deviation, violations, quality events and pharmacovigilance issues.

Site Management activities: Site qualifications, provide study team with updates, follow up with regulatory submissions and approval, review draft eCRF, study manuals and protocol. Performed site selection, initiation (SIV/SQV), interim monitoring (IMV), and close-out visits (COV), SDVs/SDRs, eTMF review and IP accountability (inventory, dispensation, and reconciliation)

Primary Oncology study contact to CROs, industry sponsors, etc. for SIVs, MVs and other study related tasks. Attends cancer tumor boards conference to review cases and determine possible best trials to be enrolled in and other oncology clinical research programs. Managed open clinical trials in compliance with SOPs, protocol/amendment(s), GCP, and the applicable regulatory requirement(s). Attends to queries, case report forms, and date entry update in EDC systems for completeness.

Created, maintained and audits trial master files on vault (paper and electronic) for inspections readiness. Worked with study teams during randomization, identify specifications and develop study related materials (binders, labels, supplies) to those specifications. Kept inventory and shipping of clinical trial supplies to site/labs under expected conditions and compliance. eTMF metrics tracking, reports and milestones for on-going studies.

Engaged in clinical feasibility meetings for upcoming trials. Assisted with patient consenting and eligibility, data review and integrity as well as site visitation meetings from sponsor or CRO. Scheduled, attended and monitored different phases of study procedures in different therapeutic indications (Oncology, CNS, Cardiovascular, Med device, Infectious disease). Managed clinical trials and regulatory in compliance with FDA and other regulations.

Compliance with all FDA quality system regulations, GMPs, SOPs, ISO quality management system requirements, and good documentation practices. Assisted in the implementation of CAPA on site and completion of customers/vendors request. Contributed do safety procedures through data collections and entry.