Jorge Hoyos
San Diego
Summary
Jorge Hoyos Jr., MD, CCRA, CMI-Spanish
San Diego, California
Dr. Jorge Hoyos has been a dedicated professional in the clinical research industry since 2010, holding roles as a Senior Clinical Research Associate (CRA), In-House Auditor, Clinical Research Coordinator, and Intake Department Supervisor for Phase I-IV clinical trials. In addition to his clinical research expertise, he has served as a General Practitioner in Mexico since 2002.
In 2014, Dr. Hoyos became a Certified Medical Interpreter in Spanish (CMI-Spanish) through the National Board of Certification for Medical Interpreters (NBCMI). He further solidified his qualifications by earning certification as a Clinical Research Associate from the Association of Clinical Research Professionals on October 19, 2018.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate – Contract Consultant
Ellodi Pharmaceuticals, LLC
06.2024 - Current
- Conducted Monitoring tasks in accordance with the approved clinical monitoring plan (CMP) to include performing Site Monitoring Visits (Site Selection, Initiation, Interim Monitoring, Close-out) to ensure compliance with the Clinical Trial Protocol, SOPs, and regulatory requirements, i.e
- Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Worked with sites and vendors to drive and track subject recruitment in line with project needs
- Lead Site staff training sessions, including protocol and any vendor provided devices and systems and ensured accurate training documentation
- Managed investigative site performance by maintaining regular phone and email contact between monitoring visits with site staff to provide support and address any findings to align with project goals and timelines
- Identified site process failure and protocol deviations and suggested corrective/preventative actions to bring the site into compliance and decrease risks that may have led to quality issues
- Reviewed and validated clinical site activities, ensuring precise data collection and reporting as per ALCOA-C principles
- Ensured data capture accuracy through Case Report Form (CRF) review, Source Data Review (SDR), and Source Data Verification (SDV) as applicable through onsite and/or remote monitoring activities
- Created and assisted with the management and resolution of data queries to maintain data integrity
- Reported any safety issues, quality issues and subject safety concerns to the Clinical Management Team and/or the Sponsor’s Medical Monitor expeditiously and followed up on findings, action items, and all issues through resolution
- Supported the development, implementation, and review of study materials, including CRFs and informed consent form (ICF) documents
- Assessed, managed and reconciled Investigational Product (IP) through physical inventory and records review; assisted site staff with IP return and/or the IP destruction process via the use of interactive response technology system
- Reviewed, collected and submitted essential and trial related documents to the Trial Master File (TMF) and contributed to the ongoing quality review and final reconciliation
- Ensured that documents were complete and in place in the Investigator Site File (ISF) by completing periodic regulatory document reviews per project specifications
- Assisted with site preparation for Sponsor and/or regulatory site audit inspections as applicable
- Documented visit activities by creating detailed site visit reports, and confirmation, follow up letters and protocol deviations logs in a timely manner
- Managed business travel itinerary and maintained and completed timely expense reports according to the project guidelines
- Performed additional study tasks as assigned by the Clinical Trial Manager (e.g
- Trip report review, newsletter creation, lead CRA team calls, etc)
Sr. CRA II
Syneos Health
08.2021 - Current
- Company Overview: Syneos Health was formerly INC Research/inVentiv Health before the merger in 2017
- Responsible for monitoring all types of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility is for site management and performance, including documentation
- Site management activities include all in-house and on-site monitoring for all visit types
- May serve in Clinical Lead role
- Mentor and train junior CRAs by conducting sign-off visits and monitoring evaluation visits
- Responsible for collaboration with Central Monitors assigned to clinical research projects for which in-house centralized monitoring activities occur
- May participate in Business Development client presentations and bid defenses as requested
- May serve as a line manager to other CRAs
- Syneos Health was formerly INC Research/inVentiv Health before the merger in 2017
Sr CRA I
Syneos Health (formerly INC Research)
09.2015 - 08.2021
- Company Overview: Syneos Health was formerly INC Research/inVentiv Health before merger in 2017
- Responsible for monitoring all types of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility is for site management and performance, including documentation
- Site management activities include all in-house and on-site monitoring for all visit types
- May be assigned clinical lead tasks
- May mentor and train junior-level CRAs
- Responsible for collaboration with Central Monitors assigned to clinical research projects for which in-house centralized monitoring activities occur
- May participate in Business Development client presentations and bid defenses as requested
- Syneos Health was formerly INC Research/inVentiv Health before merger in 2017
In-House Auditor/Lead Clinical Research Associate
Precision Research Institute
San Diego
11.2014 - 09.2015
- Worked directly with Principal Investigator and their site staff to ensure compliance with study requirements for multidisciplinary domestic and Phases I - III clinical trials
- Reviewed all site processes to ensure compliance with Good Clinical Practices and Investigational Regulatory procedures
- Monitored site and personnel for specific protocol observances including: CRF completion, review of source documents, drug accountability and documentation of necessary regulatory affairs
- Prepared accurate and timely monitoring reports and followed action items though resolution
- Trained site staff on study related vendor websites EDC, IVRS, IWRS, etc
Lead Clinical Research Coordinator
Precision Research Institute
San Diego
01.2012 - 10.2014
- Coordinated multidisciplinary Clinical Research Trials for the Principal Investigator
- Documented in source documents
- Filed Essential Documents
- Completed Investigational Product Accountability
Intake Coordinator
Synergy Clinical Research Center
National City
01.2010 - 11.2011
- Intake Department supervision
- Developed marketing strategies for clinical research subject recruitment and retention, for a shared Psychiatry Research Site/Multiple Provider Psychiatry Practice
Education
Doctor of Medicine MD - General Practitioner
Universidad Autónoma de Baja California
Mexico01.2002
Additionalexperience - Cdmsystemexperience
- TMF
- Electronic Diaries
- Electronic TMF review
- IMPACT Experience
- IWRS
- InForm EDC
- Rave EDC
- TrialMaster EDC
- Clinical One EDC (Oracle based)
- Veeva Vault
- Wingspan
Certification
- Certified Clinical Research Associate, ACRP, 10/01/18
- Certified Medical Interpreter (Spanish), National Board of Certification for Medical Interpreters, 03/01/14
Languages
Spanish, Speaking, Reading, Writing (100%)
Researchtherapeuticexperience
- Analgesia - Headache, Migraine
- Cardiovascular - Coronary Syndrome, Acute
- Hypertension, Arterial
- Endocrinology/Metabolism - Diabetes Mellitus, Type 2
- Gastroenterology - Eosinophilic Esophagitis, Ulcerative Colitis, Chronic Constipation, Opioid-Induced Constipation, Crohn's disease, Esophagitis, Gastroparesis, Irritable Bowel Syndrome, Sedation
- Hepatology - Cirrhosis, Hepatic
- Immunology / Inflammatory - Osteoarthritis
- Infectious Disease - Infection, Hepatitis C
- Neurology - Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease
- Psychiatry - Bipolar Disorder, Depression, Mania, Cognitive Impairment, Schizophrenia
- Respiratory - Asthma, Chronic Obstructive Pulmonary Disease
Biography
Jorge Hoyos Jr., MD-Mexico/CMI-Spanish, CCRA, San Diego, California, Dr. Jorge Hoyos has been in the clinical research industry since 2010 and has experience as a Sr. CRA (both as an independent contractor and FTE), In-house Auditor, Clinical Research Coordinator, and Intake Department Supervisor for phase I-IV clinical trials. Jorge Hoyos also has experience as a General Practitioner of Medicine (MD) in Mexico since 2002., Certified Medical Interpreter-Spanish, National Board of Certification for Medical Interpreters, 03/14/14, Clinical Research Associate, Association of Clinical Research Professionals, 10/19/18
Languages
Spanish
First Language
Timeline
Senior Clinical Research Associate – Contract Consultant
Ellodi Pharmaceuticals, LLC
06.2024 - Current
Sr. CRA II
Syneos Health
08.2021 - Current
Sr CRA I
Syneos Health (formerly INC Research)
09.2015 - 08.2021
In-House Auditor/Lead Clinical Research Associate
Precision Research Institute
11.2014 - 09.2015
Lead Clinical Research Coordinator
Precision Research Institute
01.2012 - 10.2014
Intake Coordinator
Synergy Clinical Research Center
01.2010 - 11.2011
- Certified Clinical Research Associate, ACRP, 10/01/18
- Certified Medical Interpreter (Spanish), National Board of Certification for Medical Interpreters, 03/01/14
Doctor of Medicine MD - General Practitioner
Universidad Autónoma de Baja California
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