Clinical Research Systems
Resume:
Adriane Miranda
Winchester, CA ***** 619-***-**** *********@*****.***
www.linkedin.com/in/adriane-miranda-8017a6a
CLINICAL SYSTEMS SPECIALIST
Dynamic, strategic, results-driven Integrated Processes Specialist offering expertise in optimizing clinical systems / Clinical Trial Management System, ensuring data integrity, and providing frontline technical support to clinical staff in clinical research. Innovative partner, effective communicator, and problem solver, known for building strong partnerships to lead system enhancements that improve operational efficiency and compliance in clinical trials, leveraging troubleshooting, user training, and cross-functional collaboration to maintain and archive clinical systems. Collaborative leader and resourceful team contributor with demonstrated success in directing diverse, cross-functional teams to support Clinical Team Leads, Clinical Research Associates, and Project Managers across all phases of clinical trials, from start-up to closeout, including Adult ADHD, Schizophrenia, Alzheimer's Disease, Bipolar Disorder, and Obesity studies.
CORE COMPETENCIES
Reporting Training Mentoring Research Documentation Process Improvements Audits Vendor Management Project / Program Management Client / Partner / Stakeholder Engagement TECHNICAL PROFICIENCIES
● Other: Clinical systems management Electronic Trial Master File management Regulatory compliance User acceptance testing Microsoft Word Excel Spreadsheet Management Microsoft Outlook Experienced in Lotus Notes Siebel CTMS StudyHub InnTrax InFORMant PowerPoint
Microsoft Project Right Fax WebEx Teams Zoom Salesforce Sharepoint
● Clinical Trial Experience: Senior Clinical Trial Assistant / Clinical Assistant - Phase 2, Oncology / Phase 3, Adult Attention Deficit Disorder (ADHD) / Phase 3, Bipolar Disorder / Phase 2, Schizophrenia / Phase 4, Alzheimer's Disease / Phase 4, Schizophrenia Project Associate / Project Assistant - Phase 2, Bipolar Disorder / Phase 3, Bipolar Disorder
● Therapeutic Experience: Neurology, ADHD Psychiatry, Bipolar Disorder Psychiatry, Schizophrenia
Gastrointestinal, Gastrointestinal Cancer
CERTIFICATIONS
● Barnett Accreditation, Fundamentals GCP EXAM for support staff, 2011, 2012
● ITIL certification, 2016
EXPERIENCE
IQVIA, Temecula, CA January 2010 - March 2025
IPT Specialist Clinical Systems Specialist, Remote Managed clinical systems - InnTrax, InFORMant, EDM, and CTMS, to support study setup, data integrity, and compliance.
● Created and updated study templates, processed study updates, and conducted Quality checks and User Acceptance Training
● Provided end-user support via ServiceNow and CTMS Chat, troubleshooting and escalating issues.
● Led system enhancements, knowledge transfer sessions, and global Super User meetings.
● Maintained investigator / site databases, coordinated data updates, and managed reports.
● Updated clinical research guidance documents to improve clarity and usability. IQVIA, Temecula, CA
Senior Clinical Assistant
Assisted the Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that tracked site compliance and performance within project timelines.
● Collaborated with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
● Assisted with periodic review of study files for accuracy and completeness.
● Collaborated with CTL on the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
● Assisted with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
● Served as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
● Assisted in training and orienting new staff and mentoring less experienced CTAs.
● Accompanied CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
● Performed assigned administrative tasks to support team members with clinical trial execution. IQVIA, San Diego, CA
Clinical Assistant
Leveraged the scope of work and standard operating procedures to assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
● Assisted with periodic review of study files for accuracy and completeness.
● Assisted CTLs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
● Assisted with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
● Executed as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
● Performed assigned administrative tasks to support team members with clinical trial execution. IQVIA, San Diego, CA
Project Associate Project Assistant
Set up and maintained all project documentation files, records, and application files.
● Coordinated all information and communications for assigned projects.
● Updated and maintained internal databases, tracking systems, and project plans with project- specific information.
● Prepared and distributed status, tracking, and project reports.
● Prepared presentation materials for internal / external meetings and project summary data.
● Coordinated project team and customer meetings, identifying and planning appropriate medium - Web, telecom, face-to-face, and ensuring arrangements were handled appropriately.
● Determined and planned all meeting requirements.
● Took and recorded minutes, notes, and actions at assigned meetings, distributing and following up accordingly.
● Coordinated with other project support staff within and across the Global Project Management Unit to identify and consolidate support processes.
● Ensured that tasks were conducted in compliance with standard processes, policies, and procedures and met quality and timeline metrics.
● Served as backup contact for the internal project team as designated by the project manager.
● Undertook project management activities as directed by the project manager. ADDITIONAL RELEVANT EXPERIENCE
● HEALTH AND HUMAN SERVICES, Payroll Clerk, County of San Diego,San Diego, CA
● TREASURER TAX COLLECTORS,Debit Memo Clerk Intermediate Clerk Typist, County of San Diego, CA
● WHEREHOUSE ENTERTAINMENT, Administrative Assistant, Redwood City, CA
● WHEREHOUSE ENTERTAINMENT, Assistant Manager, San Diego, CA
● RUBIO'S RESTAURANT WHEREHOUSE ENTERTAINMENT CHARLOTTE RUSSE, Sales Associate, San Diego, CA
● SECURITY PACIFIC BANK, Customer Service Representative, San Diego, CA EDUCATION
Bachelor of Arts, Comparative Literature
San Diego State University, San Diego, CA
PROFESSIONAL DEVELOPMENT
● Computerized Accounting Certificate, Regional Opportunities Program, San Diego, CA
● Computerized Bookkeeping Certificate, Sawyer College of Business, San Diego, CA
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