Ashley Gesino, BSN, RN

Aubrey, TX ***** 469-***-**** ad416h@r.postjobfree.com

SUMMARY

Registered Nurse (RN) and experienced clinical research professional (former CCRC) with extensive experience in diverse clinical settings, including Investigative Site, CRO, and Sponsor. Adept in navigating the intersection of healthcare practice and clinical research. Demonstrated expertise in ICH-GCP, HIPAA, FDA regulations, study start-up, clinical trial management, and study close-out. Proactive and self-motivated with a proven track record of success in managing complex projects across all phases of clinical trials. Expertise extends to meticulous TMF development and maintenance, and proficient management of local and central IRB submissions, ensuring compliance and efficiency in both medical and research landscapes.

WORK HISTORY

American College of Radiology Reston, VA (Remote)

Regulatory Administrator Oct 2023 – Jan 2024

Managed all site and sponsor level correspondence to and from central IRB, ensuring timely and accurate communication

Acted as the primary IRB liaison, managing inquiries and facilitating collaboration between IRB, project managers, and stakeholders

Managed regulatory documentation for submissions, reviews, amendments, deviations, and adverse event reporting

Reviewed and signed-off on all site submissions to the IRB, ensuring compliance with regulatory standards

Provided expert guidance to project managers on regulatory matters such as complex IRB submissions and protocol adherence

Modified and submitted protocol documents, including informed consent forms (ICFs) and subject-facing materials, during protocol amendments to ensure accuracy and regulatory compliance

Memorial Sloan Kettering Cancer Center New York, NY (Remote)

Research Regulatory Associate Aug 2022 – February 2023

Maintained comprehensive, GCP/FDA compliant, regulatory files/binders for protocols, including, but not limited to, Form FDA 1572(s), Financial Disclosure Forms (FDFs), Delegation of Authority logs, training logs, laboratory reference ranges and CLIA documentation, CVs and Licenses, Investigator Brochures (IBs), and safety reports

Managed all document revisions and central and local IRB submissions for protocol amendments and compliance reporting

Generated and submitted reports [e.g. Continuing Review Reports (CRRs), Data and Safety Monitoring reports, toxicity/adverse event documentation], and performed advanced queries for Principal Investigator (PI), disease management team, sponsoring agency, IRB, etc.

Ensured Serious Adverse Events (SAEs) were completed and reported to IRB and sponsor, if applicable, as per institutional and protocol requirements

Reported deviations to PI and/or Manager, and ensured timely reporting to IRB and Sponsor, as applicable

Prepared for internal and external audits by conducting pre-audit review of regulatory files

Performed complete QA review of all regulatory documents necessary for CRR preparation and submission

Addressed regulatory issues/queries noted on Sponsor monitoring visit summaries

Drafted Note(s) to File and memos, obtained approval from PI, and submitted to IRB and/or sponsor as needed

Ensured PI, participating investigators/consenting professionals, and research staff were trained on protocol and protocol amendments, and maintained up-to-date training logs

Coordinated multiple projects with competing priorities and deadlines, as needed, based on clinical trial protocol directives and study volume

Led regular research team meetings to disseminate regulatory updates and ensure comprehensive understanding and compliance across the team

Medical City Denton Denton, TX

Registered Nurse (RN), Operating Room Feb 2022 – Aug 2022

Collaborated with surgical team and multidisciplinary healthcare providers to ensure safe, high-quality patient care

Provided direct nursing care and supervised non-licensed nursing staff in accordance with scope of practice and established policies

Managed patient safety by implementing operative policy and procedures, including patient identification, site verification, patient positioning, and counting of sponges, instruments, and sharps

Continuously monitored and communicated patient condition to surgeon and anesthesia, as appropriate

Ensured continuity of care through appropriate discharge planning, patient education and coordination of services

Stephens & Associates, Inc. Richardson, TX

Study/Research Staff Scheduling Coordinator & IRB Assist Dec 2017 – Dec 2018

Certified Clinical Research Coordinator (CCRC) II Oct 2017 – Dec 2018

Clinical Research Coordinator II Jun 2017 – Oct 2017

Clinical Research Coordinator I Mar 2016 – Jun 2017

Determined study scheduling based on cost proposals, study budgets, and staff and bioinstrumentation availability, while managing all ongoing study-related scheduling

Regular correspondence with Sponsors, contract physicians, and photographers regarding study scheduling, contractor availability, and data analysis deadlines

Delegated study responsibilities such as clinical grading and photography based on qualifications and availability

Created Institutional Review Board (IRB) submission and study documentation timelines for all studies

Collaborated with IRB Coordinator to ensure timely completion of IRB submission packets

Reviewed, and participated in the development of, proposed study protocols and final reports

Created all protocol-related documents (ICFs, H&Ps, CRFs, etc.) and online study questionnaires

Conducted clinical trials according to study protocol, ICH-GCP, Standard Operating Procedures (SOP), and Federal regulations

Instructed clinical staff in scientific and procedural aspects of various studies, including Informed Consent Form (ICF) documentation and data collection procedures

Assessed subject eligibility through methods such as screening interviews, reviews of medical records, and discussions with Principal Investigator (PI)

Maintained an open line of communication with PI and biostatistics department to ensure enrollment quotas were met, study flow was even and controlled, and to address any potential data queries

Identified protocol issues or discrepancies, informed appropriate personnel, and collaborated in problem resolution efforts such as protocol revisions and amendments

Managed the requisition, collection, labeling, storage, and shipment of investigational product (IP) and specimens

Prepared, maintained, and submitted, when necessary, records of study activity, including Informed Consent Forms, test material dispensation records, and adverse event (AE) reports

Prepared for all quality assurance audits and site monitoring visits

EDUCATION

Bachelor of Science in Nursing May 2024

Texas A&M University

Associate Degree in Nursing May 2021

Collin College

Bachelor of Science in Healthcare Studies December 2015

University of Texas at Dallas

Associate of Science December 2012

Collin College

CERTIFICATIONS & LICENSURE

CITI Program Human Subjects Protection (HSP) August 2025

CITI Program Good Clinical Practice (GCP) August 2025

Registered Nurse (RN) January 2025

License number: 1055564

BLS for Healthcare Providers January 2026

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