Michael Victor, CCRP

Spearhead regulatory strategy, study start-up, and maintenance activities for 40+ active Phase I-IV clinical trials across multiple therapeutic areas within high-volume dermatology research sites in New York City. Successfully launched 28+ clinical trials within a one-year period, driving site activation timelines through efficient regulatory planning, document collection, and sponsor collaboration. Lead preparation, review, submission, and tracking of regulatory documents including initial submissions, amendments, continuing reviews, safety reports, protocol deviations, and study closures with IRBs and sponsors. Serve as the primary regulatory resource for investigators, sponsors, CROs, and clinical research teams, facilitating regulatory compliance and timely study execution. Maintain audit and inspection-ready ISF/eISF systems in accordance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and site SOPs. Direct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), monitoring visits, audit readiness activities, and study close-out processes. Drive implementation and optimization of electronic regulatory systems, improving operational efficiency, document accessibility, and compliance oversight across multiple studies. Draft and revise informed consent forms (ICFs), HIPAA authorizations, and regulatory correspondence, including Notes to File (NTFs), while ensuring adherence to regulatory and ethical requirements. Partner cross-functionally with sponsors, CROs, investigators, and site leadership to proactively resolve regulatory challenges, mitigate compliance risks, and maintain study timelines. Consistently deliver complete regulatory start-up packages within accelerated 2–3 week timelines, supporting rapid site activation and enrollment readiness.

Implement research studies in compliance with COG, NCI, FDA, GCP, NACHO, and local/international regulations. Act as the primary liaison between the hospital and regulatory authorities, addressing queries, providing updates, and ensuring compliance. Oversee protocol management, including team training, ethical approval, cost-efficiency, and timely study activation. Report adverse events (AEs) and serious adverse events (SAEs) to regulatory bodies and ethics committees, adhering to strict timelines. Ensure site readiness for COG/FDA audits and maintain updated knowledge of regulatory changes, communicating updates to the research team. Manage source documentation and data extraction to ensure accurate study results. Prepare, review, and submit regulatory documents such as protocols, consent forms, and investigational brochures to IRBs and other authorities. Maintain regulatory binders and documentation to ensure compliance with guidelines. Manage and report deviations and AEs, conduct quality control on study documents across therapeutic areas and phases, and support training for site staff with quality content. Evaluate inspection findings to ensure compliance and maintain current SOPs for study conduct. Identify process improvement opportunities based on audit/inspection observations. Maintain QA records and study files while managing grant applications, IRB, GCO, and other regulatory filings. Ensure proper documentation of subject data through chart reviews and maintain source documents. Serve as the key contact with the Clinical Trials Support Unit (CTSU) for protocols, funding, Central IRB, and Medidata Rave® activities. Prepare for monitoring visits and lead the initiation of clinical research studies within the department and institution.

• Develop and maintain procedures for data entry, linking data, and documentation. • Work closely with faculty investigators and research administration staff to ensure that analytic work and data is consistent with regulations. • Maintains data quality management • Maintain and validate data for record keeping • Recorded and handled data input for the OBGYN Tumor board within Red Cap • Standardizing data management procedures such as documentation for departmental operating producers. • Reviewed, analyzes, and validates data to ensure consistency and accuracy based on specific guidelines • Ensure data accuracy through the reviewing of reports of confidential patient information • Coordinated CMEs for principal investigator • Maintain and organize patient care operations • Assist clinical staff in ensuring and achieving clinical quality measure. • Regularly attends weekly staff meetings, daily tumor boards, monthly IRB meetings, professional seminars, workshops, etc. • Organize and maintain all documentation required by the Investigator, sponsor/CRO and institution. This includes regulatory binders, source documentation, case report forms, and research charts. Prepares progress and data reports on the progress of research projects in terms of recruitment/retention, data collection/entry, missing data.

Maintained efficient work flow both on-site and remote Regularly maintaining relationships between members and clients of the organization Constructing monthly memos for the company Maximize productivity rates by proactively providing feedback on day to day activities Managed accounts receivable Coordinated the purchasing of business supplies and materials

Provided technological support for campus staff Schedule room for meeting and events Processing staff’s files and work for the institutional review board Greeted and proactively assisted the various visitors in a timely manner