Clinical Research 2 5
Resume:
MISS JESSIE RENEE D. FERNANDEZ
SAN ANTONIO, TEXAS
Fernandez JD, CV 16Aug2024 Page 1 of 5
CANDIDATE PROFILE
Jessie Renee is a motivated, customer-focused research personnel with more than 14 years of experience in the clinical research and pharmaceutical industry. Her depth of experience managing clinical trials consists of all phase I, II, III, and IV trials including the implementation of study protocols, include research development/bench science, protocol development, feasibility, patient enrollment, clinical monitoring, quality close-out activities across North America. Ms. Fernandez holds a bachelor’s degree in Biology from the University of the Incarnate Word. THERAPEUTIC AND INDUSTRY SUMMARY
Therapeutic Units & Indications (yrs)
• Cardiology: Metabolic and Critical Care (5 yrs), Prolonged Field Care (2.5 yrs), Tactical Combat Casualty Care
(2.5 yrs)
• Gastroenterology: NASH/NAFL-D (1 yr)
• Immunology: Pediatric Bone Marrow Transplant (1 yr), En Route Care Research (2 yrs)
• Neurology: Algorithm Efficacy EEG (2.5 yrs)
• Physiology: Hemorrhagic Shock (5 yrs)
• Respiratory: Emergency Airway (4 yrs), Devices (2.5 yrs), Rapid Sequence Intubation Medications (4 yrs), Prolonged Field Care (2.5 yrs), Tactical Combat Casualty Care (2.5 yrs)
• Emergency Medicine: Acute Pain (2 yrs), Surgical Respiratory Interventions (4 yrs), Approved Critical Care Interventions (4 yrs), Retrospective Trauma Care (2.5 yrs)
• Oncology: Pancreatic, Breast, Colorectal, Lung, Head and Neck, Ovarian (1.5 yrs) Study Phases
• PH I, II, III, IV Studies
Patient Populations
• Pediatrics, Neonatal, Healthy Volunteers, Patient Volunteers Global/Regional Scope
• North America
EDUCATION
• University of the Incarnate Word, San Antonio, Texas, USA Bachelor of Science, MAY 2010
LICENSES & CERTIFICATES
• Certified Clinical Research Coordinator, 2021
PROFESSIONAL EXPERIENCE
START CANCER CARE FOR RESEARCH, SAN ANTONIO, TEXAS, USA CLINICAL RESEARCH STUDY COORDINATOR, APR 2023 – PRESENT
• Monitor overall day to day conduct of assigned trials in accordance with specified protocol requirements, SOPs, and GCPs to ensure integrity.
• Review study forms created and revised for assigned trials to ensure protocol compliance.
• Implement initial protocol and amendments, trained staff involved in patient treatment and management.
• Worked with the Principal Investigator to complete and submit SAE reports.
• Attended and presented patient updates on safety calls weekly.
• Assisted with data entry into EDC systems.
• Answer and resolved queries from medical monitors and sponsor team.
• Screened patients for protocol qualification and enrollment.
• Performed quality assurance checks on patient packets prior to trial enrollment for accuracy MISS JESSIE RENEE D. FERNANDEZ
SAN ANTONIO, TEXAS
Fernandez JD, CV 16Aug2024 Page 2 of 5
PPD, SAN ANTONIO, TEXAS, USA
ASSOCIATE CLINICAL DATA TEAM LEAD, JUL 2022 – FEB 2023
• Acts as the assistant lead data manager for one or more projects supporting the lead data manager by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks.
• Applies relevant components of the project protocol to daily tasks with guidance.
• Delivers study specific training to junior associates for assigned projects.
• Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision.
• Assists with specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development.
• Monitors for risks to deadlines and escalates appropriately.
• Creates and maintains data management project documentation.
• Participates in team and client meetings and supports the lead data manager with risk management on allocated projects.
• Provides input into project forecasting of hours and identification of resource requirements.
• Monitors study metrics and runs project-specific status reports for management.
• Reviews data management deliverables for allocated projects following documented guidelines.
• Produces project-specific status reports for management, PM and/or clients on a regular basis. SENIOR CLINICAL DATA ASSOCIATE, NOV 2021–JUL 2022
• Performed all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.
• Provided direct client feedback and excellent customer service for database designing
• Supported the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
• Reviewed data listings for accuracy and consistency of data.
• Acted as point person and subject matter expert for specialized study-specific processes.
• Generated, tracked, and resolved data clarifications and queries and made changes to the clinical database as required.
• Contributed to the improvement of data management processes on a global level.
• Produced project-specific status reports for management and/or clients on a regular basis.
• Provided training and work direction to junior staff as required. PINNACLE CLINICAL RESEARCH, SAN ANTONIO, USA
CLINICAL RESEARCH COORDINATOR, JUL 2020 – NOV 2021
• Worked closely with Quality Control, Investigators and Study Manager(s) to assure initiation and successful completion of Phase II-III Clinical Trials.
• Ensured conduct of studies were conducted in accordance with ICH-GCP, federal regulations, and company policy (SOPs).
• Attended onsite/virtual initiation visits (SIVs), sponsor training/requirements, prepared for interim monitoring visits, addressed data corrections on site with monitor oversite.
• Thoroughly worked with the Documentation & Compliance and Quality Assurance team for data documentation correctness and proper query resolution.
• Obtained and documented adverse events/serious adverse events, medical history, concomitant medications in accordance with the protocol.
• Maintained and organized up to date subject records on all subjects under consent according to study guidelines.
SYNEOS HEALTH, SAN ANTONIO, USA
CLINICAL RESEARCH COORDINATOR, NOV 2019 – MAY 2020
• Worked with authorized representatives for pediatric study enrollments per protocol. Maintained and organized patient binders/chart/master trial files for protocols.
• Attended weekly meetings to debrief and present study status updates. MISS JESSIE RENEE D. FERNANDEZ
SAN ANTONIO, TEXAS
Fernandez JD, CV 16Aug2024 Page 3 of 5
• Assisted with daily medical record abstraction.
• Collected specimen samples per protocol requirements and prepared samples for shipment.
• Entered data into electronic data capture systems. US ARMY INSTITUTE OF SURGICAL RESEARCH, FORT SAM HOUSTON, USA CLINICAL RESEARCH COORDINATOR, SEP 2014 – SEP 2019
• Clinical Research Coordinator on multiple clinical studies of varying levels (retrospective, prospective, in- patient, multicenter, in-patient) within the Emergency Department, Intensive Care Unit and Laboratory setting from start up to closure and publication.
• Provided ongoing site training to acquire quality data for the purposes of analyses in accordance with good clinical practice guidelines.
• Maintained updated regulatory records for research team and conducted on-site audits to confirm compliancy.
• Conducted submission of grants and managed administrative duties related to grant management. WORLDWIDE CLINICAL TRIALS, SAN ANTONIO, TEXAS, USA RESEARCH ASSOCIATE II, AUG 2010 – JUL 2014
• Worked closely with Study Coordinators, Investigator, and the Study Conduct Manager to assure initiation and successful completion of Phase 1 Clinical trials.
• Ensured the conduct of the studies were conducted in accordance with GCP Guidelines, federal regulations, and company policy (SOP’s).
• Attended site initiation visit (SIV’s), sponsor specified training/requirements, prepared for interim monitoring visits, addressed corrections on site per monitor oversite, answered questions and concerns.
• Thoroughly worked with the Documentation & Compliance and Quality Assurance team for data documentation correctness and proper query resolution.
• Obtained and documented Adverse Events/ Serious Adverse Events (AE’s/SAE’s) and concomitant medications in accordance with the protocol.
• Maintained and organized up to date subject records on all subjects under consent according to study guidelines.
•
PROFESSIONAL AFFILIATIONS
• Member of the Association of Clinical Research Professionals, Washington DC, Virginia, USA PUBLICATIONS AND PRESENTATIONS
Publications:
• Hinojosa-Laborde C, Fernandez JD, Muniz GW, Nawn CD, Burns RK, Le TH, Porter KB, Hardy JT, Convertino VA. Effect of Pain and Analgesia on Compensatory Reserve. J Trauma Acute Care Surg. 2017Jul;83(1 Suppl 1): S92-S97. doi: 10.1097/TA.0000000000001544.
• Schauer SG, April MD, Naylor JF, Fisher AD, Cunningham CW, Ryan KL, Thomas KC, Brillhart DB, Fernandez JD, Antonacci MA. QuikClotTM Combat Gauze Use by Ground Forces in Afghanistan. J Spec Oper Med. Summer 2017;17(2):101-106.
• Schauer SG, April MD, Naylor JF, Simon EM, Fisher AD, Cunningham CW, Morissette D, Fernandez JD, Ryan KL. Chest Seal Placement for Penetrating Chest Wounds By Prehospital Ground Forces in Afghanistan, J Spec Oper Med. 2017 Fall;17(3):85-89.
• Schauer SG, Fisher AD, April MD, Carter R, Cunningham CW, Aden JK, Fernandez JD, Delorenzo RA. Battlefield Analgesia: Adherence to Tactical Combat Casualty Care Guidelines. J Spec Oper Med. 2015 Spring;15(1):85-9.
• April MD, Schauer SG, Brown CA, Ng PC, Fernandez J, Fantegrossi AE, Maddry JK, Summers S, Sessions DJ, Barnwell RM, Antonacci MA. A 12-month descriptive analysis of emergency intubations at Brooke Army Medical Center: a National Emergency Airway Registry study. US Army Med Dep J. 2017 Oct- Dec;(3- 17):98- 104.
• Schauer SG, Fernandez JR, Roper JL, Brown D, Jeffers K, Srichandra J, Davids NB, April MD. A randomized cross-over study comparing surgical cricothyrotomy techniques by combat medics using a synthetic cadaver MISS JESSIE RENEE D. FERNANDEZ
SAN ANTONIO, TEXAS
Fernandez JD, CV 16Aug2024 Page 4 of 5
model. Am J Emerg Med. 2018 Apr;36(4):651-656. doi: 10.1016/j.ajem.2017.11.062. Epub 2017 Nov 27
• Schauer SG, April MD, Naylor JF, Cunningham CW, Ryan KL, Thomas KC, Brillhart DB, Fernandez JD, Antonacci MA. Prehospital Trauma Registry Experience with Intraosseous Access. J Spec Oper Med. Spring 2019;19(1):52-55.
• Schauer SG, Fisher AD, Stolper KA, April MD, Cunningham CW, Carter R, Fernandez JD, Pfaff JA. Prehospital administration of antibiotic prophylaxis for open combat wounds in Afghanistan: 2013- 2014. J Special Operations Medicine. J Spec Oper Med. Summer 2018;18 (2):53-56.
• April MD, Arana A, Pallin DJ, Schauer SG, Fantegrossi A, Fernandez JD, Maddry J, Summers S, Antonacci MA, Brown CA. Emergency Department Intubation Success with Succinylcholine Versus Rocuronium: A National Emergency Airway Registry Study. Ann Emerg Med. 2018 Dec;72(6):645- 653. doi: 10.1016/j.annemergmed.2018.03.042. Epub 2018 May 7.
• Schauer SG, Kester NM, Fernandez JD, April MD. A randomized, cross-over, pilot study comparing the standard cricothyrotomy to a novel trochar-based cricothyrotomy device. J Emerg Med. 2018 Jan 30. pii: S0735-6757(18)30065-2. doi: 10.1016/j.ajem.2018.01.064. [Epub ahead of print]
• Schauer SG, Rice C, Naylor JF, April MD, Fisher AD, Cunningham CW, Fernandez JD, Shreve BP, Bebarata VS. Prehospital resuscitation performed on hypotensive trauma patients in Afghanistan: The Prehospital Trauma Registry Experience Military Medicine. Mil Med. 2019 May 1;184(5-6):e154- e157. doi: 10.1093/milmed/usy252.
• Basel PS, April MD, Arana AA, Fernandez JD, Schauer SG. Cerebral blood flow changes during palpation of external airway structures in healthy volunteers. PLoS One. 2020; 15(7): e0236256. Published online 2020 Jul 27. doi: 10.1371/journal.pone.0236256.
Presentations:
• San Antonio Universities Research Forum, Guest lecture (2017). Lecture topic: Emergency Airway Management at San Antonio Military Medical Center: A 12-Month Descriptive Analysis
• Military Health Science Research Symposium, Guest lecture (2018). Lecture topic: A Descriptive Analysis of Casualties Evacuated from the AFRICOM Area of Operations. LANGUAGES
• Native Tongue: English
REGULATORY EXPERIENCE
• Significant experience in regulatory affairs in USA
• Experience with regulatory authorities and associated business teams THERAPEUTIC EXPERIENCE AND EXPERTISE
• Cardiology: Metabolic and Critical Care, Prolonged Field Care, Tactical Combat Casualty Care
• Gastroenterology: NASH/NAFL-D (Ph II-IV)
• Immunology: Pediatric Bone Marrow Transplant (Ph II-III), En Route Care Research
• Neurology: Algorithm Efficacy EEG Device
• Other Areas of Expertise: Algorithm Efficacy (prospective), Algorithm Development (preclinical), Healthy Volunteers
• Physiology: Hemorrhagic Shock
• Respiratory: Emergency Airway, Devices, Rapid Sequence Intubation Medications, Prolonged Field Care, Tactical Combat Casualty Care
• Emergency Medicine: Acute Pain, Surgical Respiratory Interventions, Approved Critical Care Interventions, Retrospective Trauma Care
CLINICAL TRIAL EXPERIENCE
• Cardiovascular: A phase III, Assessment of the efficacy of an algorithmic device in pregnancy population postpartum
• Cardiovascular: A phase IV, Evaluation of a model for compensatory reserve during lower body negative pressure in humas
MISS JESSIE RENEE D. FERNANDEZ
SAN ANTONIO, TEXAS
Fernandez JD, CV 16Aug2024 Page 5 of 5
• Gastroenterology: A phase II, Evaluation of the safety and efficacy in a double blinded study of XXX in NASH and NAFLD patients
• Gastroenterology: A phase II, Evaluation of the safety and efficacy in a double blinded study of XXX in NAFLD and elevated LDL-Cholesterol
• Gastroenterology: A phase III, Evaluation of the efficacy in an open label of XXX in primary biliary cholangitis patients
• General Medicine: A phase III, Development and validation of a hemorrhagic algorithmic device in the emergency department
• General Medicine: A phase IV, A comparison of layperson tourniquet success: Device 1 vs Device 2
• General Medicine: A phase IV, A comparison of nonmedical soldier tourniquet success: Device 1 vs Device 2
• General Medicine: A phase IV, A comparison of surgical airway techniques in synthetic cadaver model and large animals, a randomized cross-over study
• General Medicine: A phase IV, airways and aid bags
• General Medicine: A phase IV, Defining care in non-doctrinal medical theater: a descriptive analysis
• General Medicine: A phase IV, Effects of a pain medication on physiological responses to moderate or severe hemorrhage in small animals
• General Medicine: A phase IV, Ethnography of novel drug abusers to target substance abuse intervention
• General Medicine: A phase IV, Life-saving interventions performed in the emergency department setting during combat operations
• General Medicine: A phase IV, National emergency airway registry (NEAR)
• General Medicine: A phase IV, the analgesic effects of RSI medications following orthopedic trauma in small animals
• General Medicine: Retrospective, An assessment status of the current tactical combat casualty care
• General Medicine: Retrospective, En route care, advancing trauma care through handoffs (E-CATCH)- a prospective trial to improve handoffs, patient safety, and anticipate the need for lifesaving medical interventions
• Neurology: A phase III, Assessment of the efficacy of a hand-held algorithmic EEG device to screen traumatic brain injury
• Physiology: Cerebral blood flow changes associated with palpitation of the airway in preparation for cricothyrotomy: a prospective cohort study
COMPUTER EXPERIENCE
• MS Office (Word, Excel, PowerPoint)
• Windows OS
• EndNote
• Prism- GraphPad
• EDC (Medidata, Rave, ERT/IRT, Oracle, RedCap, CRIO, OmniComm, TrialMaster, Judy, Adaptive, CTMS, InForm, Almac, Veeva Vault, OnCore, Aria)
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