PROFESSIONAL SUMMARY: Experienced Clinical Research Professional seeking career advancement with a CRO where I can make a positive contribution by utilizing my clinical research expertise. In-depth knowledge of clinical trial policies and procedures, study protocols, GCP guidelines, ICH guidelines, regulatory clinical trial documentation requirements, IRB documents submittal, sponsor electronic data capture systems for data entry, SOP's, site monitor visit processes, study start up/close-out, and study internal and external audits. Integral team-player with excellent decision making, interpersonal and communication skills. AREAS OF EXPERTISE * Management of multiple oncology Phase I-III clinical research trials (solid tumor studies-GI, Melanoma, Urology, GYN, Breast, Head/Neck, SAR, and MD) * Effectively meet deadlines and consistently exceed expectation for timely data collection and submission * Train and provide guidance to less experienced clinical and non-clinical research staff * Support clinical trials for CRO by providing meticulous clinical trials data management and reports. Maintain databases, queries, and reports perform data entry, check reviews, database audits and validate study protocols expertise in databases such as InForm, Medidata Rave, Oracle, ClinTrak, DataLabs, RedCap, & OnCore * Maintain accurate records of Adverse Events and expediting reports of Serious Adverse Events to sponsors * Maintain Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) in compliance with ICH guidelines * Ensures compliance with protocol guidelines and requirements of IRBs * Maintain thorough close communication with principal investigators, sponsor CRA's, site clinical research coordinators and other related study personnel to improve protocol compliance and meet timelines * Responsible for maintaining the confidentiality of protected health information and medical records in accordance with the Health Insurance Portability Accountability Act (HIPAA) * Collaborate with medical professionals and clinical research staff to determine changes in subjects' conditions * Serve as point-of-contact for Clinical Research Professionals on and off research site * Participate in site-initiation visits (SIV) for study start-up and assist Lead CRA with specific data management protocol requirements including review of source documentation, case report forms, regulatory materials, drug accountability, and assist in final closure of study * Ability to contribute and/or interpret protocol to create CRFs and edit check specifications * Maintain protocol requirements for patient required clinic visits, test procedures, and drug accountability requirements * Complete knowledge of GCP, ICH and FDA guidelines including understanding of regulatory requirements * Ability to manage multiple priorities by applying time & task management approach * Monitor data expeditiously to reduce data discrepancies, perform source document verification, retrieves case report forms (CRFs), and perform query resolution in a timely manner * Prepared for and participated in trial audits conducted by sponsors and other oversight entities such as Compliance Office * Review site monitor follow up letters/reports and implement follow up or corrective action as needed CLINICAL RESEARCH EXPERIENCE
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