Felix Ramos Email & Phone Number

• Conduct on-site monitoring visit to ensure data efficacy, subject safety, protocol compliance and overall inspection readiness• Ensure study deliverables are met by all assigned study sites and ensuring assigned sites are meeting key miles stones and interim analysis deadlines.• Utilize Risk Based Monitoring strategies to identify Key Risk Indicators and performance trends to ensure site is maintained at optimal performance • Utilize Root Cause Analysis to mitigate recurrent or critical issues within study sites and implement Corrective and Preventative Action Plans when needed• Conduct study site start-up including staff training, Site Initiation Visits, regulatory document collection, supply receipt and accountability, enrollment monitoring, • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site• Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification etc.)• Provide applicable updates for site related documentation for filing in the electronic Trial Master File (eTMF)• Assure maintenance of the Investigator Site File in the eTMF• Maintaining, logging, and reporting regular communication with sites• Review source documents related to reporting of subject data and safety events• Complete remote CRF review, using electronic data capture systems• Assist sites in retention of study subjects

• Ensure subject safety above all else and adherence to all safety procedures outlined in protocols, SOPs and guidelines.• Conduct and organize clinical trials in accordance with FDA/GCP and ICH guidelines and regulations and ensure data quality and guiding fellow coordinators through the processes of the studies.• Assisting management with day-to-day scheduling and visit assignment, devising strategies to tackle issues to improve efficiency and completing complex tasks.• Prepare study for internal, third party or FDA inspection.• Promote teamwork and better communication between team members and other teams.• Ensure all aspects needed for proper study execution (supply maintenance, training, staff communication, etc.) are continuously addressed in time and effectively.

Orlando, Florida

• Specialized on a multitude of mortgage products from conforming (FHA, conventional, VA, USDA) to non-conforming (bank statement, foreign national, tax ID).• Updating all parties involved throughout all the milestones while meeting deadlines and simultaneously advancing multiple applications forward while resolving hindrances in an expedited manner in a fast-paced work environment.

Orlando, Florida

• Ensure patient safety is maintained by closely monitoring collected data from each patient visit• Ensure staff compliance with FDA regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, internal SOPs, sponsor requirements, and adherence protocol• Monitor studies ranging from Phase II to Phase IV, and for a diverse spectrum of conditions

Rochester, New York Area

Project manager at the Clinical Trial Coordination Center. International site assignment in countries such as USA, UK, Spain, Germany, Italy, France, Australia, and Israel.DUTIES & RESPONSIBILITIES• Ensure site compliance with FDA regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, internal SOPs, sponsor requirements, and adherence to the study protocol• Assists in the planning of study activities such as Investigator Meetings, global protocol training for new amendment implementation, interim analysis, among others• Training new staff at all clinical sites and ensure new training is completed when required• Development and review of study protocol and informed consent forms to be approved by local Institutional Review Board• Monitor clinical site performance, conformance to protocol through metrics and communicate results and observations to sponsor and senior leadership• Proposing solutions for problems presented by sponsor or sites and coordinating the implementation of sponsor and senior leadership decisions• Assisting in study planning, logistics, problem solving, and developing newer processes to improve study performance and establish performance trends

University Of Rochester Medical Center

• Supervising and training other staff and ensuring optimal laboratory performance• Creating detailed reports for senior leadership and inclusion in publications• Working with other departments to coordinate, plan, manage and carry out extensive and long-term experiments according to federal and institutional regulations