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Click here or scroll down to respond to this candidateCandidate's Name , BSN, RNAubrey, TX Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLESUMMARYRegistered 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 HISTORYAmerican College of Radiology Reston, VA (Remote)Regulatory Administrator Oct 2023 Jan 2024Managed all site and sponsor level correspondence to and from central IRB, ensuring timely and accurate communicationActed as the primary IRB liaison, managing inquiries and facilitating collaboration between IRB, project managers, and stakeholdersManaged regulatory documentation for submissions, reviews, amendments, deviations, and adverse event reportingReviewed and signed-off on all site submissions to the IRB, ensuring compliance with regulatory standardsProvided expert guidance to project managers on regulatory matters such as complex IRB submissions and protocol adherenceModified and submitted protocol documents, including informed consent forms (ICFs) and subject-facing materials, during protocol amendments to ensure accuracy and regulatory complianceMemorial Sloan Kettering Cancer Center New York, NY (Remote)Research Regulatory Associate Aug 2022 February 2023Maintained 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 reportsManaged all document revisions and central and local IRB submissions for protocol amendments and compliance reportingGenerated 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 requirementsReported deviations to PI and/or Manager, and ensured timely reporting to IRB and Sponsor, as applicablePrepared for internal and external audits by conducting pre-audit review of regulatory filesPerformed complete QA review of all regulatory documents necessary for CRR preparation and submissionAddressed regulatory issues/queries noted on Sponsor monitoring visit summariesDrafted Note(s) to File and memos, obtained approval from PI, and submitted to IRB and/or sponsor as neededEnsured PI, participating investigators/consenting professionals, and research staff were trained on protocol and protocol amendments, and maintained up-to-date training logsCoordinated multiple projects with competing priorities and deadlines, as needed, based on clinical trial protocol directives and study volumeLed regular research team meetings to disseminate regulatory updates and ensure comprehensive understanding and compliance across the teamMedical City Denton Denton, TXRegistered Nurse (RN), Operating Room Feb 2022 Aug 2022Collaborated with surgical team and multidisciplinary healthcare providers to ensure safe, high-quality patient careProvided direct nursing care and supervised non-licensed nursing staff in accordance with scope of practice and established policiesManaged patient safety by implementing operative policy and procedures, including patient identification, site verification, patient positioning, and counting of sponges, instruments, and sharpsContinuously monitored and communicated patient condition to surgeon and anesthesia, as appropriateEnsured continuity of care through appropriate discharge planning, patient education and coordination of servicesStephens & Associates, Inc. Richardson, TXStudy/Research Staff Scheduling Coordinator & IRB Assist Dec 2017 Dec 2018Certified Clinical Research Coordinator (CCRC) II Oct 2017 Dec 2018Clinical Research Coordinator II Jun 2017 Oct 2017Clinical Research Coordinator I Mar 2016 Jun 2017Determined study scheduling based on cost proposals, study budgets, and staff and bioinstrumentation availability, while managing all ongoing study-related schedulingRegular correspondence with Sponsors, contract physicians, and photographers regarding study scheduling, contractor availability, and data analysis deadlinesDelegated study responsibilities such as clinical grading and photography based on qualifications and availabilityCreated Institutional Review Board (IRB) submission and study documentation timelines for all studiesCollaborated with IRB Coordinator to ensure timely completion of IRB submission packetsReviewed, and participated in the development of, proposed study protocols and final reportsCreated all protocol-related documents (ICFs, H&Ps, CRFs, etc.) and online study questionnairesConducted clinical trials according to study protocol, ICH-GCP, Standard Operating Procedures (SOP), and Federal regulationsInstructed clinical staff in scientific and procedural aspects of various studies, including Informed Consent Form (ICF) documentation and data collection proceduresAssessed 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 queriesIdentified protocol issues or discrepancies, informed appropriate personnel, and collaborated in problem resolution efforts such as protocol revisions and amendmentsManaged the requisition, collection, labeling, storage, and shipment of investigational product (IP) and specimensPrepared, maintained, and submitted, when necessary, records of study activity, including Informed Consent Forms, test material dispensation records, and adverse event (AE) reportsPrepared for all quality assurance audits and site monitoring visitsEDUCATIONBachelor of Science in Nursing May 2024Texas A&M UniversityAssociate Degree in Nursing May 2021Collin CollegeBachelor of Science in Healthcare Studies December 2015University of Texas at DallasAssociate of Science December 2012Collin CollegeCERTIFICATIONS & LICENSURECITI Program Human Subjects Protection (HSP) August 2025CITI Program Good Clinical Practice (GCP) August 2025Registered Nurse (RN) January 2025License number: 1055564BLS for Healthcare Providers January 2026 |
