Summary
Overview
Work History
Education
Skills
Certification
Vendorexperiences
Therapeuticareas
Systemexperiences
Timeline
Generic

MELINA RAMIREZ

Glendale,CA

Summary

  • PASSIONATE CLINICAL OPERATIONS LEAD Clinical Trial Administrator
  • Clinical Operations Manager
  • Good Clinical Practice
  • Regulatory Compliance
  • Clinical Documentation Controlled Budgets
  • Start-Up
  • Trained Trial Staff Members Certified Clinical Research Associate (CCRA)
  • Minimized Study Risk
  • Enforce Trial Timelines

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Clinical Study Manager

Location ICON
08.2021 - 01.2024
  • Project managed various research projects by creating the project schedule, monitoring progress, and collaborating closely with the program lead
  • Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments
  • Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, SUR, IND
  • Mitigated risk by assessing key factors, planning effectively, and guiding execution
  • Controlled costs and prevented expense overruns while managing the study budget, timelines, and insourcing/outsourcing partners up to the required standards
  • Developed site monitoring plan and study-related manuals, as well as contributing to study concepts, protocols, clinical study reports, and other critical study documents as required
  • Took charge of vendor management, including selection, negotiation, implementation, and management of activities per Scope of Work (SOW)
  • Operated as primary study contact throughout trial conduct, facilitating regular conference calls and team meetings with appropriate functional areas, data management, and vendors
  • Managed various aspects of studies involving rare diseases across different phases of global clinical trials
  • This typically involves coordinating activities across different departments or teams to ensure smooth execution of the study protocols from the early phases of research through to later stages
  • Ensured adequate staffing, training, and resources throughout the entire trial lifecycle
  • Collected, tracked, and reported established deliverables such as specimens, queries, AE/SAE data collection, drug reconciliation/shipment, ancillary, investigational products, and patient enrollment, etc
  • Supported local study teams in coordinating planning, start-up, and maintenance of clinical studies, adhering to established budgets, timescales, and clinical trial standards
  • Coached and mentored junior Clinical Study Specialists on processes, study, technical, and behavioral competencies including resolving difficult situations
  • Secured all necessary regulatory and ethical approvals by preparing, compiling, revising, and tracking all necessary documents with diligence, timeliness, and accuracy
  • Prepared and compiled all Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies
  • Navigated all logistical aspects of clinical studies according to GSK operating standards and Good Clinical Practice (GCP), ensuring appropriate support and timeline/budget adherence.

Senior In-House CRA II

PRA Health Sciences
05.2019 - 08.2021
  • Ensured the current versions of the required trial documents, trial-related materials, and supplies were provided to the investigational site within the required time frames
  • Advanced study goals while maintaining compliance with relevant training and SOPs
  • Negotiated site-requested changes to the Confidential Disclosure Agreement
  • Verified and vetted investigators and IEC/IRBs against exclusion databases (HRPDB), IEC/IRB registrations, and alerts, maintaining study integrity
  • Achieved consistently successful delivery of site start-up, in-house site management, site feasibilities and close-out activities, fulfilling all internal and external client requirements
  • Played a key role in creating and maintaining clinical project documents such as Clinical Management Plans, Monitoring Guidelines, Site Operations Manuals, and more
  • Adhered to contract and budget by determining, tracking, and reviewing milestones, tasks, timelines, and project hours for all the clinical activities for assigned projects.

In House CRA I

PRA Health Sciences
10.2012 - 05.2019
  • Enhanced Clinical Trial Management System by conducting regular updates and new entries
  • Documented all site communications and generated required contact reports as needed
  • Recognized with Bee Award for exceptional performance of trial leadership and management
  • Facilitated team communication across departments, as well as external facilities
  • Upskilled staff members across multiple sites by delivering targeted training
  • Streamlined budgeting processes by integrating contracts into Access and eTMF systems
  • Monitored ICH-GCP compliance while maintaining the quality of on-site files
  • Manage IP document review and preparation for internal and Pre-audit inspections
  • Participated in multiple workgroups to develop processes improving IMP management between internal departments
  • Reviewed and validated local IP label text
  • Reviewed and updated local IP related QDs and SDs and system tools to ensure quality and compliance within CSU, and aligned with corporate direction, regulatory authorities and partners
  • Worked with internal and external associates regarding any IP complaints, variations in temperature and humidity storage conditions or other issues concerning IP to determine acceptability for use including proper documentation that is required for the file and training as applicable
  • Monitored and reviewed IP tracking tables to ensure ongoing completion by monitoring teams including temperature excursions
  • Maintained and archived
  • IP documentation for trial master study files.

Trial Management Associate I

Schering Plough
03.2009 - 12.2011
  • Promoted the seamless executes and multiple clinical trials by coordinating documentation, collaborating with research teams, and processing budgetary expenditures
  • Delivered comprehensive clinical trial project support as a key resource to all members of the project and study team, both internal and external
  • Administered and tracked clinical trial enrollment for assigned studies
  • Assisted in the preparation and tracking of trial/initiate budgets and follow-up
  • Managed multiple clinical grants, ensuring appropriate fund use and proper documentation
  • Processed a broad range of regulatory documents, Clin-Doc, eCRF forms, and confidential documents in a timely and sensitive manner
  • Mentored and trained new hires on various systems and processes, including grants payment system, study start-up, file maintenance, and close-out activities
  • Collected coordinated study documents, lab specimen labels, and other requirements.

Education

Bachelor of Arts - Individualized Studies

Fairleigh Dickinson University
Teaneck, NJ
05.2019

Skills

  • Microsoft Outlook
  • Microsoft Teams
  • Adobe Acrobat
  • Zoom Video Communications
  • DocuSign
  • Oracle Clinical
  • WebEx
  • Google Workspace
  • Citrix
  • GCP Knowledge
  • Adverse event reporting
  • Site monitoring
  • Clinical trial management
  • Clinical Data Management
  • Patient recruitment
  • Investigator relations
  • Protocol development
  • Pharmacovigilance
  • Clinical Research
  • Study design
  • Ethics Committee Submissions
  • Regulatory Submissions
  • Training and mentoring
  • Standard Operating Procedures
  • Fluent in English
  • Data Management
  • Study coordination
  • Teamwork and Collaboration
  • Problem-Solving
  • Time Management
  • Good Clinical Practices
  • Attention to Detail
  • Problem-solving abilities
  • Multitasking
  • Multitasking Abilities
  • Reliability
  • Excellent Communication
  • Organizational Skills
  • Team Collaboration
  • Active Listening
  • Effective Communication
  • Adaptability and Flexibility
  • Decision-Making
  • Study protocols
  • Research SOPs understanding
  • Informed consent
  • Medication Dispensing
  • Task Prioritization
  • Research experience
  • Self Motivation
  • Interpersonal Skills
  • Trial management
  • Analytical Thinking
  • Professionalism
  • Goal Setting
  • Interpersonal Communication
  • Time management abilities
  • Continuous Improvement
  • Adaptability
  • Quality Assurance
  • Specimen collections
  • Documentation requirements
  • Records Management
  • Problem-solving aptitude
  • Clinical trial expertise
  • Protocol Review
  • Disease Research
  • Analytical Skills
  • Team building

Certification

  • Advanced Clinical Research Project Manager Certification (ACRPMC), CCRPS, USA
  • Certified Clinical Research Associate (CCRA), KRC International, USA, 11/01/12, NA

Vendorexperiences

ClinPhone IVRS, Covance, Medidata Rave, VeevaVault, iMediData/CTMS, VIPER, Copernicus, Sterling IRB, Advarra, Q2 Solutions, Calyx, Clario, Bioclinical, LabConnect, LabCorp, Mosiac, PhenoPath, ALMAC, Catalyst PV, Clario

Therapeuticareas

  • Cardio-Metabolic Disease Diabetes Phase I, II, III & IV
  • Hematology Leukemia Chronic Myelogenous/CML Phase I, II, III & IV
  • Hepatology Liver Disease Phase I, II, III & IV
  • Infectious Disease AntiViral HIV, Epidemiology Phase I, II, III & IV
  • Cardiovascular Congenital heart disease Phase I, II, III
  • Vaccines Covid-19 Phase I, II, III & IV
  • Neurology Alzheimer’s, Parkinson’s, Multiple sclerosis, Central Nervous System Phase I, II, III & IV
  • Oncology Blood Cancer, Hematologic, Melanoma Phase I, II, III & IV Lymphoma
  • Ophthalmology Autoimmune, Glucoma, Dry Eyes Phase II,III & IV

Systemexperiences

ClinTrial, IMPACT, Medidata, Medidata Rave, ClinPhone, Calyx, ePRO, Shared point, OneNote, Documentum eTMF, vTMF

Timeline

Clinical Study Manager

Location ICON
08.2021 - 01.2024

Senior In-House CRA II

PRA Health Sciences
05.2019 - 08.2021

In House CRA I

PRA Health Sciences
10.2012 - 05.2019

Trial Management Associate I

Schering Plough
03.2009 - 12.2011

Bachelor of Arts - Individualized Studies

Fairleigh Dickinson University

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MELINA RAMIREZ