15 Years of organizational coordination in for profit and non-profit clinical, medical research and community roles Areas of Expertise: clinical research, clinical trial coordination (setup to fulfillment), liaising between academic entities and pharmaceutical companies, medical writing, governmental and regulatory affairs, event organization, project management, coordination of intricate international teams, multicultural integration, complex project execution in developing countries Delivering optimal performance in high demand, large budget, expectations driven and time sensitive environments Excelling in effective communication, chain of command and high-profile relationships Self-motivated, driven, a lifelong learner in technological, systematic and professional categories, focused on effective time management and attention to details
Overview
16
16
years of professional experience
Work History
Project Manager
08.2022 - 02.2023
CS Clinical Trials
Led the Planning and Setup, Monitoring, and Closeout phases of study management
Monitored study timelines and managed the financial components of each program/study
Identified potential study risks and mitigations and escalated as appropriate
Managed internal/external negotiations and promoted collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations
Applied problem-solving strategies to address customer issues and maintained issue tracking documentation to monitor progress and ensure timely resolution to customer escalations
Presented study services at Investigator Meetings or site initiation meetings as needed
Assisted with training new members of the Project Management team.
Critical Care/ Epilepsy Research Coordinator, Scientific Engagement Coordinator
YALE UNIVERSITY, SCHOOL OF MEDICINE, Comprehensive Epilepsy Center
03.2021 - 08.2022
Responsible for all operational aspects of Clinical Research and trial oversight in the studies assigned, ensuring on-time delivery, within budget and scope, and compliance with GCPs, SOPs, and internal and external expectations
Managed and coordinated biorepositories involving multiple regional, national, and international teams of physicians, local research coordinators, patients, and other research stakeholders
Conducted data collection, analysis, and reporting of studies, and elaborated manuscripts for publication
Important Achievements
Prepared and executed an IRB protocol of a unique, highly complex biorepository, a one of a kind project, that involves the reception of samples from around the world through a simplified MTA mechanism, very few institutions worldwide have achieved something like this
It included writing, approval, logistics and opening for accrual of the project
Directed RAISE, a clinical study of high value for Status Epilepticus patients, the orchestration, timing and synchronicity of which was a particularly demanding equilibrium to achieve
Liaised with the various stakeholders involved with the NORSE study, a position which requires ample tact to satisfy the expectations of financers, the scientific input of doctors and researchers and regulatory oversight from administrative departments at Yale
Coordinated all NORSE institute events, particularly the annual symposium with over 400 physicians in attendance: including planning, registration, and technical support, essentially overhauling and more efficiently organizing both the registration system and presenter platforms using Redcap
Reduced substantially expenditures of supplies by changing the distribution system to all contributing sites for biological material sample collection
Overhauled data collection methods and reporting practices from contributing sites by using existing technologies to track inventory collected and centralized processing technology in the Yale office
Elaborated and approved in record time, protocols, regulatory documents and contracts related to SAFER, a complex medical device study involving industry, 4 external academic centers and Yale University
Designed a system within the current Redcap technology to collect data in a more organized, efficient and regulatory compliant way
Developed a training program for the various participating sites and center coordinators related to NORSE and as well related to RAISE for nurses, fellows and residents at Yale
Utilized existing scheduling software to schedule and coordinate meetings and academic exchange of the NORSE/FIRES steering committee (a worldwide conglomeration of in demand physicians with very busy schedules)
Succeeded in performing and exceeding the duties of the role entrusted, often going beyond what was strictly required, which demanded highly levels of creativity, especially during covid-19 when there was a shortage of senior staff available for training or regular staff to perform duties
Many of the tasks required 24/7 availability
Board Advisor/Editor
TRAVELADEPT.COM LLC
06.2009 - 07.2020
Chief
Developed and implemented the annual strategic plan
Reviewed outcomes and metrics for evaluating content impact and performance
Oversaw compliance with all legal and fiduciary responsibilities of the LLC
Reviewed all editorial content for style, accuracy and strategic vision
Coordinated community events as a associate leader
Facilitated ongoing education of elementary, secondary and adult formation
Incorporated marginalized communities into the institutional plan (elderly, infirm, minorities)
Advised the Diocesan office in matters of bio- and medical ethics
Created representation for Hispanic community stakeholders and an association of Hispanic medical doctors in Memphis
Initiated a multi-cultural advisory board of physicians, caregivers and volunteers in medical research to bring complex bioethics cases to discuss in search of solutions
Advised on bioethics and medical ethics for Hispanic patients arriving to Memphis for treatments in St Jude’s hospital
Member of the board of directors of Run for Haiti by participating in recruitment efforts, fundraising and traveling to the organization’s 2 hospitals in Haiti 2 times a year to deliver supplies and train volunteers
Education
Universidad Autónoma de Centro América San José
master’s - medicine
Universidad Autónoma de Centro América
Postgraduate -
Harvard Medical School
Cambridge, MA
Global Clinical Scholars Research Program -
2023
Bachelor’s - health sciences
Universidad Autónoma de Centro América San José
2019
Master’s - divinity, Bioethics
Pontificia Universita della Santa Croce
2013
Medical Sciences
Universidad Privada del Valle
2006
Medicine Pre-Clinical Program -
Universidad del Sinu
2002
Skills
Clinical Research
Analytical Skills
Interpersonal Skills
Clinical Trials
Project Management
Medical Affairs Expertise
Data Analysis
Industrial and Academic Related Skills:
Time Management
Planning
Attention to Detail
Project Oversight
Clinical Data Management
Talent Management
Leadership Development
Multicultural Team Leadership
Research and Development (R&D)
Technical Writing
Multicultural Leadership
Medical & Technical Writing
Coaching
Customer Service
Excellent Communication
Ability to build effective relationships with trial center staff and colleagues
Strong numeracy skills
Flexibility
Proficiency in Microsoft Office Suite, Mac OS, and Windows
Project Planning
Project Scheduling
Project planning and development
Strategic Planning
Project tracking
Customer Relations
Stakeholder Communications
Staff Management
Work flow planning
Advanced problem solving
Document Management
Scope Management
Influencing skills
TRAININGS AND CERTIFICATIONS
Redcap and Encore Management Software
Basic life support (CPR) certification
Certified to handle toxic, hazardous, infectious or radiological substances
Protection of Human Subjects Certification
Foundational HIPPA in privacy and security
Shipping and export controls
Good clinical practice
Human subject protection advanced
Compliance assessment
Chaperone hospital training
Harassment free workplace
Prevention and response to sexual misconduct
Patent Policies
References
References: Available upon request
Affiliations
American Epilepsy Society, 2021-Present
American Academy of Neurology, 2017 – Present
American Neurological Association, 2018 – Present
American Medical Students Association, 2017 – Present
American Infectious Diseases Society, 2017 – Present
Medical Students Association Costa Rica, 2015 – Present
Multiple Sclerosis Association Costa Rica, San Jose, Costa Rica 2017-2020
Languages
English, Spanish, Italian, Portuguese, and Classical Languages)
Timeline
Project Manager
08.2022 - 02.2023
Critical Care/ Epilepsy Research Coordinator, Scientific Engagement Coordinator
YALE UNIVERSITY, SCHOOL OF MEDICINE, Comprehensive Epilepsy Center