Jose A. Ramirez DNP, MSN, MBA, RN
Miami,USA
Summary
Dynamic and results-driven clinical research and healthcare professional with diverse experience aiming to leverage an extensive background in clinical research, healthcare administration, and education. With over 15 years of experience in managing and optimizing clinical trials. Proven track record in leading cross-functional teams, ensuring compliance with biopharma guidelines, and driving operational excellence. I am meticulous in my execution, which should reassure and instill confidence in my audience about my abilities to deliver results.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Associate Director, Site Engagement
Astra Zeneca Pharmaceuticals
02.2023 - Current
- Strengthen the relationship between sites and AstraZeneca clinical teams to enhance performance and overcome roadblocks in site feasibility, start-up, and execution, thereby becoming a partner of choice for the sites
- Over 30 direct partnerships and alliances were created in two years
- Support Operational feasibility by leveraging AstraZeneca performance data to build sustainable recruitment targets and strategies and provide early transparency on recruitment strategies and reduce cycle times by up to 40%
- Develop and maintain a working knowledge and materials of site processes and institution knowledge to guide study teams and leadership to positive decisions related to site inclusion and study management
- Manage site interactions effectively to ensure alignment of site and business expectations
- Demonstrate a comprehensive understanding of site networks, business practices, and the competitive clinical trial landscape to advise clinical teams on study-specific site selection or site management strategies
- Support local feasibility leads and liaisons in site identification and selection
- Developed a customer segmentation strategy, allowing targeted marketing campaigns and improved customer engagement.
Site Relationship Partner – Manager, SE Region & Puerto Rico
Pfizer Pharmaceuticals
07.2018 - 02.2023
- Responsible for in-country site management and oversight of assigned clinical trials to ensure patient safety and quality study execution by applicable prevailing laws
- With the expansion of local territory and operations in the United States, Caribbean, and Latin America
- A local expert is responsible for the assigned clinical trials and brings that expertise to support the investigator site and the site monitor in conducting clinical trials
- Throughout the Southeast Region in the United States and Puerto Rico, the expert manages over 70 clinical research sites and clinical research networks
- Accountable for managing investigator-site relationships to ensure effective clinical trial delivery, safeguard investigator-site quality, and maintain investigator engagement and satisfaction
- Organizations are selected internally by the management of (INSPIRE) clinical research internal preferred network
- Provides support to the Study Team by providing regional / country insights, updates on the evolving local clinical development environment, and cross-site insights regarding study performance
- Provide cross-study and cross-site insights into the Clinical Development Portfolio at the country level
- Areas covered include the Southeast region of the United States and the Caribbean and supporting Latin American operations.
Senior Lead Clinical Research Associate (Pfizer assigned)
Syneos Health Corporation
02.2017 - 07.2018
- Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies
- Monitor those sites to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations, and ICH-GCP principles—involvement, when required, in other areas of study management and staff training
- Contribute to the review of Pfizer and AbbVie systems and procedures, as appropriate
- Coach and mentor inexperienced/less experienced colleagues on monitoring competence
- Contribute to the culture of process improvement, with a focus on streamlining our processes, adding value to our business, and meeting client needs
- Recognize, exemplify, and adhere to company values, which center around a commitment to People, Clients and Performance
- Independently and proactively coordinate the necessary activities required to set up and monitor a study.
Senior Site Manager- Clinical Research Monitor
PRA Health Sciences
02.2016 - 03.2017
- Manage activities of clinical investigative sites to ensure the successful execution of the protocol
- Conducting site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies following federal regulations, GCP and ICH Guidelines and company SOP's
- Ensuring regulatory inspection readiness at assigned clinical sites and reporting monitoring activities and study site conduct wholly and accurately
- Study stages handled: study start-up, monitoring, study closeout.
Administrative Nurse, Quality Management- Accreditation Specialist
U.S Department of Veterans Affairs, (VHA)
07.2014 - 12.2015
- Leadership and management for planning, organizing, coordinating, and controlling overall operations of the continuous survey readiness program, including federal regulatory requirements, internal survey processes, and external accreditation standards compliance performance
- Developed and implemented a proactive and systematic approach to accreditation readiness
- Liaison with accreditation organizations
- This involves coordinating the completion and submission of required documents to those organizations and organizational leadership
- Ensured process for managing Joint Commission unannounced surveys, CARF surveys, and Office of Inspector General Comprehensive Assessments, including a communication plan, management of required documents, and logistical issues
- Successfully implemented and maintained the Joint Commission Accreditation in 2015 with minimal findings
- Provided administrative support to management, resulting in improved efficiency in daily operations.
Health System Specialist, Quality Improvement and Aeromedical Nurse
U.S. Department of Justice, Federal Bureau of Prisons: FCI
05.2012 - 07.2014
- Responsible for ensuring that all quality management protocols, including quality improvement and disease management, are appropriately identified and processed in adherence to the Federal Bureau of Prisons guidelines and plan policies
- Reported communicable diseases to the appropriate authorities and reviewed Federal Bureau policy and clinical guidelines program review standards
- Centers for Diseases Control guidelines and Standard Joint Commission under Ambulatory Care successfully passed over the period of employment, ACA, OSHA, and inspections
- Managed the quality committee structure such as Quality Improvement, Credentialing, Care Management, Utilization Management, Peer Review, and Compliance
- Develops quality improvement plan including performance improvement projects (PIP) from credentialing processes, case management, utilization review, peer review, review of grievances, and review and response to adverse events at the Federal Bureau of Prisons
- Managed emergencies and provided emergency medical care when necessary
- Acted as a first responder in emergencies, providing medical assistance and coordinating with emergency services during medical transport.
Senior Clinical Research Associate
ICON Plc. Clinical Research
11.2011 - 05.2012
Senior Clinical Research Associate
Product Pharmaceutical Development (PPD)
01.2011 - 12.2011
Clinical Research Associate
Kendle International Corporation
02.2007 - 05.2010
Clinical Project Manager and Monitor, Canada- Latin America
Abbott Vascular Canada-Latin America Operations
03.2006 - 02.2007
Interventional Nurse and Invasive-Cardiovascular Technologist
Palmetto General Hospital
01.2004 - 03.2006
Education
Doctor of Nursing Practice (DNP) - Healthcare Leadership
Grand Canyon University
Master of Science in Nursing (MSN) - Nursing Informatics
American Sentinel University
Master’s in Business Administration (MBA) - Business Administration / Human Resources Management
Metropolitan University - UMET Miramar
Bachelor of Science in Nursing (BSN) - Nursing / Minor, Human Resources
Pontifical Catholic University
Associate Degree, Cardiovascular Technology (AA) - Invasive Cardiovascular Technology
National School of Technology
Certification
- Florida RN License #9328942
- Puerto Rico Registered Nurse license
- BLS
- ACLS
- CCT Certified Cardiovascular Credentials. Cred # 00025596
- Critical Care -Certified registered nurse certification
- Automated External Defibrillator Certified Instructor (AED Org)
- Intermediate Healthcare Analytics Certificate (Veterans Administration Engineering college)
- Certified in Healthcare Quality and Safety (George Washington University)
- Certified professional in Healthcare Management (International Healthcare Management forum)
- CTMS clinical trial management systems
- IVRS
- Medidata
- Inform
- Siebel cross training
- Cerner systems cross training
- Perceptive Impact cross training Inform
- Vista health
- EPIC
- Veeva
Additional Information
United States Health and Human Services / Active duty of the National Disaster Medical Assistance Team Registered Nurse. 2020- Present (NDMS) Disaster Medical Assistance Teams provide high-quality rapid-response medical care when public health and medical emergencies overwhelm state, local, tribal, or territorial resources. In the aftermath of natural and technological disasters, acts of terrorism, and during disease outbreaks, DMAT members are on location protecting the health and saving lives. DMAT members also serve behind the scenes to provide medical support at national special security events.
Therapeuticareaexperience
- Cardiovascular
- Medical Devices
- Diabetes
- Respiratory
- Vaccines
- Infectious disease
- Rare diseases
- Internal Medicine
- Metabolic Rheumatoid /Psoriatic arthritis/
- Inflammation
- Woman’s Health
- Dermatology
- Oncology Phase IV
- Phase I, II, III, and IV all specialties.
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Associate Director, Site Engagement
Astra Zeneca Pharmaceuticals
02.2023 - Current
Site Relationship Partner – Manager, SE Region & Puerto Rico
Pfizer Pharmaceuticals
07.2018 - 02.2023
Senior Lead Clinical Research Associate (Pfizer assigned)
Syneos Health Corporation
02.2017 - 07.2018
Senior Site Manager- Clinical Research Monitor
PRA Health Sciences
02.2016 - 03.2017
Administrative Nurse, Quality Management- Accreditation Specialist
U.S Department of Veterans Affairs, (VHA)
07.2014 - 12.2015
Health System Specialist, Quality Improvement and Aeromedical Nurse
U.S. Department of Justice, Federal Bureau of Prisons: FCI
05.2012 - 07.2014
Senior Clinical Research Associate
ICON Plc. Clinical Research
11.2011 - 05.2012
Senior Clinical Research Associate
Product Pharmaceutical Development (PPD)
01.2011 - 12.2011
Clinical Research Associate
Kendle International Corporation
02.2007 - 05.2010
Clinical Project Manager and Monitor, Canada- Latin America
Abbott Vascular Canada-Latin America Operations
03.2006 - 02.2007
Interventional Nurse and Invasive-Cardiovascular Technologist
Palmetto General Hospital
01.2004 - 03.2006
Doctor of Nursing Practice (DNP) - Healthcare Leadership
Grand Canyon University
Master of Science in Nursing (MSN) - Nursing Informatics
American Sentinel University
Master’s in Business Administration (MBA) - Business Administration / Human Resources Management
Metropolitan University - UMET Miramar
Bachelor of Science in Nursing (BSN) - Nursing / Minor, Human Resources
Pontifical Catholic University
Associate Degree, Cardiovascular Technology (AA) - Invasive Cardiovascular Technology
National School of Technology
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