Blanca N Velazquez
Summary
Experienced Regulatory Affairs Specialist with expertise in regulatory compliance and policy implementation. Skilled in managing regulatory submissions, overseeing compliance audits, and ensuring adherence to industry standards. Demonstrated proficiency in handling regulatory documentation and conducting thorough risk assessments.
Overview
27
27
years of professional experience
Work History
Regulatory Specialist
Elligo Health Research
02.2023 - 11.2023
- Maintain confidentiality, prioritizes, and manages work effectively and provides exceptional customer service internally and externally
- Liaises with Site, Client, and IRB throughout the study to assist with regulatory maintenance including: Updating and filing of essential documents
- Processing of IRB submissions, approval and corresponding documents
- Performing quality reviews of the eISF
- Manages all SUSARs received throughout the study: Receipt, organization, filing and collect signatures of reports
- Ensures completeness of the eISF prior to monitoring visits and at the study closeout visit
- Performs the procedures required for the eISF archiving
- Assists with maintenance of department's mailbox
- Gathers, enters and/or updates data to maintain company records and databases
- Performs other duties and responsibilities, as required
Regulatory Affairs Coordinator
Texas Oncology
06.2016 - 02.2023
- Under general supervision coordinates the research and administrative activities in support of projects for the Regulatory Affairs Department
- Works with regional regulatory coordinators to maintain and coordinate the collection of critical documents
- Supports and adheres to the Oncology Compliance Program, to include the Code of Ethics and Business Standards
- Maintain Protocol Regulatory Documents in compliance with local Standard Operating Procedures
- Maintain Texas Oncology Research Systems, including ensuring appropriate access to all staff and sponsor representatives and troubleshooting any issues
Data Coordinator
Cancer Care Center of South Texas
09.2012 - 06.2016
- Enter data to the various Electronic Data Capturing systems, answering queries as they arise, make appointments for monitor, (coordinate appointments for Principal Investigator, pharmacy and Lab) and work with monitors to resolving queries in a timely manner
Data Coordinator
South Texas Oncology Hematology
03.2009 - 07.2012
- Responsibility of data entering to the various Electronic Data Capturing systems, answering queries as they arise, make appointments for monitor, (coordinate appointments for Principal Investigator, pharmacy and lab) and work with monitors to resolving queries in a timely manner
Clinical Research Coordinator
InVision Consultants LLC
06.2008 - 03.2009
- Responsibilities included but not limited to: Under direct supervision of a Physician, was responsible for maintaining protocol compliance for all patients on clinical trials most trials during this time period were Nephrology studies
- Data entering to various data sites per protocol guidelines; make sure appointments are schedule and are kept according to protocol guidelines
- Sit with individual monitors; work with little or no supervision
Clinical Research Coordinator I
Cancer Care Center of South Texas
10.2007 - 05.2008
- Responsibilities included but not limited to: Under direct supervision of a physician and Nurse Manager, Was responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials most trials I worked on during this time period were Oncology trials
- Collaborate with physician in determining eligibility of patients for clinical trials
- Provide education to staff and patients
- Keep all Regulatory Documentation in order for USO studies and Out-of-Network studies
- Ensure site research quality by practicing in compliance with US Oncology Research, Inc
- (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations
- Supports and adheres to US Oncology compliance Program, to include the Code of Ethics Business Standards
Data Coordinator II
Cancer Care Center of South Texas
10.2006 - 10.2007
- Responsibilities included but not limited to: Under minimal supervision I am responsible for the collection, coordination, processing and quality control of clinical trial data
- Assist with screening patients for research protocols
- Maintain research protocol information, regulatory documents and other research files as applicable
- Work in compliance with US Oncology Research (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice and all applicable federal, state, and local regulations
- Supports and adhere to the US Oncology compliance Program to include the code of Ethics and Business Standards
Research Study Associate
T.R.U.E Research Foundation
10.1997 - 09.2007
- As a Study Research Associate I was responsible for managing the conduct of all clinical research protocols in the Breast Cancer Prevention Program sponsor by the National Adjuvant Breast & Bowel Project
- Provide education/information about clinical research protocols to associated health care personnel
- Establish and maintain a record keeping system to insure adequate documentation of each clinical protocol in accordance with FDA requirements
- Recruit and enroll participants who meet the study's inclusion/exclusion criteria
- Collect study data and provide participants care according to protocol
- Coordinate and examine varying types of data from multiple sources (medical records, clinical laboratories, patient input, etc.) for accuracy and consistency within protocol requirements and in accordance with military regulations, good clinical practices and sponsor requirements
- Evaluate participant's response to experimental treatment; observe and record participant's reaction of symptoms in response to treatment; assist the investigator in assessing value of the study in relation to patient progress; evaluate methodology and quality of data collected, and determine need for changes in procedures
- Assist with development of data summaries and presentation material, assist with data presentation
- Routinely report the status of participant's enrollment and study progress to the investigator and the sponsor's representatives
- Monthly report the status of participant enrollment and study progress to headquarters
- Monitor inventory and arrange re-stocking of study supplies as required by the protocol, i.e., the case report forms, study drug (amount and expiration date), lab tubes or other required items
- Assist with sample collection, processing and shipment as required per protocol
- Conduct participant education in regards to the protocol and study medication and cardiac status
- Interact with investigator and sponsors representatives and resolves issues/questions regarding study conduct
Data Manager
University of Texas Health Science Center
09.1996 - 09.1997
- In this setting I worked closely with the physician and investigator of the National Adjuvant Breast & Bowel Project sponsor protocols and also Southwest Oncology Group sponsor protocols
- As the Data Manager/Study Research Associate or Clinical Research Coordinator of the above position it requires little or no supervision my main responsibility was and is to keep the program available to the participants making sure the office is functioning according to protocol procedure, knowledge of Word Perfect, Ten-Key Operations, Excel, fax machine, copier and filling must be kept up to date and available for the Program Director/Principal Investigator and the Research Nurse when available
Education
Paralegal Certification -
International Business College
Diploma - General
Ysleta High School
Skills
- Meticulous Quality Assurance
- Effective Organization
- Self-Motivated Task Management
- Effective Team Collaboration
Timeline
Regulatory Specialist
Elligo Health Research
02.2023 - 11.2023
Regulatory Affairs Coordinator
Texas Oncology
06.2016 - 02.2023
Data Coordinator
Cancer Care Center of South Texas
09.2012 - 06.2016
Data Coordinator
South Texas Oncology Hematology
03.2009 - 07.2012
Clinical Research Coordinator
InVision Consultants LLC
06.2008 - 03.2009
Clinical Research Coordinator I
Cancer Care Center of South Texas
10.2007 - 05.2008
Data Coordinator II
Cancer Care Center of South Texas
10.2006 - 10.2007
Research Study Associate
T.R.U.E Research Foundation
10.1997 - 09.2007
Data Manager
University of Texas Health Science Center
09.1996 - 09.1997
Diploma - General
Ysleta High School
Paralegal Certification -
International Business College
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