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Project Manager Clinical Research

Location:
Dayton, OH, 45410
Posted:
July 06, 2023

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Resume:

Sabré “Sam” M. Stevens-Topie, BA, LATG

**** ***** **** *****, **********, OH 45042

Mobile: 513-***-****

adx4p0@r.postjobfree.com

Education

Miami University of Ohio

Dates Attended: August 2011-June 28, 2014

Majors: Zoology and Chemistry of Life Processes

Degree Received: BA Awarded: August 15, 2014

University of Cincinnati-Blue Ash

Dates Attended: March 2009-June 2011

Major: Veterinary Technology/Biology

Degree Received: None/Transferred to Miami University

Professional Memberships

American Chemical Society (ACS), since August 2014

American Association for Laboratory Animal Science (AALAS), since April 2016

DoD Security Clearance Currently Held

Secret (acquired September 2015)

Availability to Start

Immediately

Most Recent/Current Work Experience:

PriMED Clinical Research

JOB TITLE: Clinical Research Coordinator

JOB DESCRIPTION:

conduct medical exams and collect data in accordance with the protocols from the subjects (blood pressures, ECGs, temperature, phlebotomy draws, respirations, pulse, conduct eye exams w/Physician PIs, process blood samples for analysis, collect previous medical history and current medications, convey the protocol requirements for the subject and attain consent to participate, maintain subject charting, communications with the sponsors and vendors, coordinate site visits with the vendors and sponsors, including maintaining minutes and records of all correspondences, maintain records and collect temperatures for specimens and the corresponding equipment in which they are housed as well as the investigation product (IP) usually vaccines or oral medications)

-maintain training via CITI, ACRP, and various other sponsor and vendor required organizations in order to maintain protocol and GCP compliant

-utilize MS Office programs (word, excel, Teams, publisher, PowerPoint, outlook, one note, access) to create documents, presentations, spreadsheets, and various other standard research documentation and organization for tracking and accountability purposes.

LENGTH OF EMPLOYMENT: January 10, 2023 – Current

SUPERVISOR: Crystal Osman, MA, CCRC Site Manager PriMED Clinical Research

USAFSAM 711 RHB via contract thru AFC (Alaka’ina Family of Companies)

JOB TITLE: RHBAM Biomedical Research Coordinator/Research Assistant

JOB DESCIPTION:

Aide in the creating of research proposals, conduct market analysis of emerging science and technology, support the collection, analysis, and reporting of research data.

Perform a variety of administrative tasks associated with research: obtain and maintain applicable IRB, HRPO, IACUC, IBC, MOU, data sharing agreements and provide auditing trails to assure protocol compliance; identify problems and/or inconsistencies and monitor subjects’ progress to include documentation and reporting of adverse events, recommending corrective action as appropriate; and assist in preparation of amendments to protocols and/or modifications to study design as appropriate.

Assist PIs with developing and administrating project budgets, tracking expenditures, and

generating project financial data supporting program management and research lead duties.

coordinate with the PI any approvals required for expenditures; assist with routing approval

documents, and maintain tracking of where documents are within the approval process.

prepare project progress reports for USAF leadership. Schedule meetings across multiple stakeholders, engaging and coordinating efforts with subject matter experts, conducting literature reviews, data collection and management,

managing local requirements for document clearances per Scientific and Technical Information (STINFO) regulations.

Assist in drafting, preparation, and/or editing of research publications, including abstracts, posters, quartlerly technical reports for currently 7 projects, manuscripts, and slide presentations utilizing MS Office programs (Word, Excel, Sharepoint, Access, Powerpoint, Publisher, OneNote, Teams)

Perform a variety of technology-based tasks associated with research, to include creating research documents, management spreadsheets, slideshow presentations, as well as building and maintaining research databases.

Assist in the management, coordination, and quality improvement of the systematic collection, aggregation, coding, entry, storage, retrieval, and reporting of relevant patient data from DOD clinical databases.

Support the efforts of the PIs through creation of spreadsheets of data; data extraction/collection, coding, evaluation, and interpretation. The contractor employee shall identify inconsistencies or discrepancies in medical documentation and recommend processes or guidelines for resolution. The contractor employee shall compile and enter data from multiple data sources.

Recommend solutions to improve processes and maximize mission accomplishment through efficient utilization of resources.

•Attend meetings, as required, with government and civilian organizations, program managers, academia, clinicians, and subject matter experts.

LENGTH OF EMPLOYMENT: December 1, 2021-January 6, 2023

SUPERVISOR: Irene Solano, Project Manager, AFC (Alaka’ina Family of Companies) Contact Number: 210-***-****

USAF CSTARS-University of Cincinnati Research Laboratory Support

currently via contracted thru Cape Fox Federal Integrators, previously contracted thru STI Technologies Inc.

JOB TITLE: Senior Research Laboratory Associate

JOB DESCRIPTION:

Research Project Management/Coordination Responsibilities:

Assist PIs and PM with the development of research initiatives and protocols by helping establish procedural standards, and methodology for procedures while executing an advanced skillset in experimental design, physical execution of experimental studies, data analysis during and post study.

Assist PM with taskers for the AFMS (DHP) funding structure and CCAR document requirements (cost proposals, SOWs, etc) both during funding of a study and equipment acquisition as well as budget assistance taskers

Assist with the editing and review of publications, manuscripts, and presentations of studies before final submission.

Assist PM with the tracking and completion of QPURS

Support the creation of complex data collection and processing systems, establishing experimental controls, organizing research results and data, assisting in the preparation of research preparing proposals and grants.

Explain and assist with the understanding of technical information to new research personal, physicians, residents, and medical students as well as train new personal in surgical and scientific techniques required for execution of studies.

Assist with organization, experimental flow management, and physical performance of research studies as related to ongoing research projects, assist with solving and in dealing with challenging technical issues as they may arise along with identifying and mitigating them before they can occur when possible, collaborate with PIs, perform study scheduling, reporting and independently perform assignments based on general guidance from PIs and DoD personnel.

Support and assist the updating of the RPD (Research Projects Database) with current information on assets, publications, and various new information

Assist with the preparation of protocol-related documents for submission to the Institutional Review Board (IRB).

Contribute effectively to the collective team effort to attain the mission goals.

Currently performing and am involved in multiple active DoD research studies.

Assist and support PM with STINFO inputting, tracking, and embargo processing for entry into DTIC

Sr Research Technologist Responsibilities: Perform various research activities involving large and small animals (usually swine and rodents). Collaborate with PIs in dealing with challenging technical issues. Conduct both macro and microscopic surgical procedures and administration of anesthesia.

Small Animal Surgical Skills: Aterial line placement via femoral, utilization of Power Lab monitoring systems, hemorrhagic shock induction, laparotomy, splenectomy, blood collection via cardiac stick, pulmonary lavage, traumatic brain injury induction, operation of small animal hypoxia chamber, MouseOx system setup and utilization in the large animal altitude chamber, Rotorod operation and utililization, penial injections, lung perfusions, circulatory perfusion via IVC catheter, carotid catheter, and cardiac stick.

Large Animal Surgical Skills: Arteriotomy, venotomy, pottsing of vessels for hemorrhage control/arterial blood pressure line/central line/hemorrhage line placement via venipuncture or venotomy/arteriotomy and utilization, whole blood collection/harvesting and resuscitation, frozen plasma reconstitution and resuscitation, line placement via external jugular or internal jugular, vascular repair, vascular stent placement and repair, REBOA placement/utilization, GAMPT monitor internal/external vascular placement/utilization, ITPR device placement/utilization, swan-gauz placement/operation/monitoring/utilization, thoracotomy, laparotomy, trocar placement/utilization for laparoscopic surgery, laparoscopic basic surgical instrument usage/procedural techniques, liver punch injury induction, splenectomy, femoral punch injury induction, lung lavage for pulmonary injury, vibration table via COCO-80x monitor (flight vibration simulation) operation, cole-parmer masterflex L/S peristaltic pump operation and utilization, moberg CNS monitoring system, ICP probe placement and utilization via Raumedic monitoring system, 6-Connect monitor probe system placement, monitoring, and utilization (wave activity), Licox placement, monitoring, and utilization (for O2, temp, and cerebral pressure), Hemedex placement, monitoring, and utilization (cerebral perfusion monitor), whole blood filtration and usage for immediate or delayed resuscitation of subject.hemorrhagic shock induction, swan-gauz placement, monitoring, bronchoscope usage and utilization, normoxia and hypoxia pulmonary induction and control, craniotomy, post mortem brain extraction, closed loop vent setup/management and utilization, large animal altitude/hypoxia chamber setup and utilization/operation, preoperative/peroperative preparation/utilization (intubation, IV placement, site preparation, IM/gas/IV anesthesia induction/operation/monitoring, EKG monitoring/placement, internal/external temperature monitoring, multichannel IV pump operation/utilization, drug/crystalloid infusions)

Bench work and Technical Item Responsibilities/Skills: Molecular biology bench skills, Rotemp operation/utilization, Multiplex operation/utiliztion, Tissue/Organ specimen perfusion and preservation for macro and microscopy histology, Istat, Flow Cytometry, ELISA, Western blot, histology, immunohistochemistry, cell culture, cell culture assays, immunocytochemistry, PCR analysis.

Research Animal Care Responsibilities: Provide Animal care related to research procedures, administering medications to lab animals orally/topically, preparing samples for laboratory examinations and recording information about an animal’s genealogy, diet, weight, medications, food intake and clinical signs of pain and distress. Perform preoperative, perioperative, peroperative, and postoperative care.

LENGTH OF EMPLOYMENT: Sept. 29, 2015-Nov. 30th, 2021

SUPERVISOR: Micheal Couture-Project Manager, Cape Fox Federal Integrators, LLC. Contact Number 571-***-****

Julia Dalton-Project Manager, STI, Inc. Contact Number: 937-***-****

Other Previous Work Experience:

Advanced Testing Laboratory (Contract Work at Proctor and Gamble)

JOB TITLE: RND Physical Testing Lab Analyst

JOB DESCRIPTION: Test samples according to company methods to generate data for product development and stability. Includes: pH testing, lotion extraction, MTS tester methods, absorption, UV/Vis testing, use of digital scale, calibration validation of various lab equipment prior to execution of testing, data entry, use of electronic laboratory notebook, use of laboratory database, Microsoft Lync for inter-departmental communication, and various other duties as assigned and needed by the lab.

LENGTH OF EMPLOYMENT: March 9, 2015 – Sept 28, 2015

REFERENCE NAME AND JOB TILE: Raymond Moss-Lab Manager, Contact Number: (937) 371-069

·ALS Environmental

JOB TITLE: General Lab Technician

JOB DESCRIPTION: Float between sample receive preparing bottle orders for clients and the sample

extraction laboratory. Sample Recieve Duties: Monitor sample fridges temps for being within set range of

thermal requirements, prepare bottle orders and sample media for clients to collect samples for analysis,

dispose of hazardous waste in accordance with ALS SOPs. Extraction Laboratory Duties: Prepare soil,

water, and various bulk samples for analysis of PAH, SVOC, DRO, and PCB levels. Wash and setup

scientific glassware. Maintain a clean and safe laboratory environment in accordance with ALS GLP

standards.

LENGTH OF EMPLOYMENT: December 15, 2014 - February 9, 2015

REFERENCE NAME AND JOB TITLE: Jessica Bookman- Organic Sample Preparation Analyst

Contact Number: 513-***-****

·ALS Environmental via Lab Support Temp Agency

JOB TITLE: Organic Prep Technician

JOB DESCRIPTION: Prepared soil, water, and various bulk and oil samples for analysis of PAH, SVOC,

DRO, and PCB levels. Wash and setup scientific glassware. Maintained a clean and safe laboratory

environment in accordance with ALS GLP standards.

LENGTH OF EMPLOYMENT: November 4, 2014 - December 4, 2014

REFERENCE NAME AND JOB TITLE: Jessica Bookman- Organic Sample Preparation Analyst

Contact Number: 513-***-****

University of Cincinnati-Blue Ash College Library

JOB TITLE: Student Assistant

JOB DESCRIPTION: Worked the circulation desk helping patrons with basic reference questions, basic campus directional information, check-in/out books or materials to students and staff using Millennium, shelf read, re-shelf materials, answer phones, and various other duties as needed by the circulation staff and librarians.

LENGTH OF EMPLOYMENT: Fall 2009 Term - Spring 2011 Term.

REFERENCE NAME AND JOB TITLE: Tammy Manger-Former Circulation Manager

Contact Number: 513-***-****

Frankfort Animal Clinic

JOB TITLE: Veterinary Technician/Kennel Manager

JOB D.ESCRIPTION: Assist the veterinarians with exams, surgical procedures, anesthesia, vaccinations, x-rays, laboratory sample analysis via ELISA snaptest, IDEX, and microscopy (blood, fecal, urinary, fungal, and parasite), pharmaceutical work, and various other medical procedures and duties as required.

LENGTH OF EMPLOYMENT: May 2007 - September 2008

REFERENCE NAME AND JOB TITLE: Stephanie Raisor-Head Technician/Office Manager

Contact Number: 502-***-****

Anderson Animal Hospital

JOB TITLE: Veterinary Technician

JOB DECRIPTION: Assist the veterinarian with exams, surgical procedures, anesthesia, vaccinations, x-rays, laboratory sample analysis (blood, fecal, urinary, fungal, and parasite), pharmaceutical work, and various other medical procedures and duties as required

LENGTH OF EMPLOYMENT: March 2004 - February 2007

REFERENCE NAME AND JOB TITLE: Tammy Caldwell, Former Tech Supervisor

Contact Number: 502-***-****

No DVM Contact Information Available Due to Owner has passed away and clinic is under new ownership/operation)

Publications

Jung AD, Friend LA, Stevens-Topie S, Schuster R, Lentsch AB, Gavitt B, Caldwell CC, Pritts TA. Direct Peritoneal Resuscitation Improves Survival in a Murine Model of Combined Hemorrhage and Burn Injury. Mil Med. 2020 Sep 18;185(9-10):e1528-e1535. doi: 10.1093/milmed/usz430. PMID: 32962326.

Morris MC, Niziolek GM, Blakeman TC, Stevens-Topie S, Veile R, Heh V, Zingarelli B, Rodriquez D, Branson RD, Goodman MD. Intrathoracic Pressure Regulator Performance in the Setting of Hemorrhage and Acute Lung Injury. Mil Med. 2020 Aug 14;185(7-8):e1083-e1090. doi: 10.1093/milmed/usz485. PMID: 32350538.

Singer KE, Morris MC, Blakeman C, Stevens-Topie SM, Veile R, Fortuna G, DuBose JJ, Stuever MF, Makley AT, Goodman MD. Can Resuscitative Endovascular Balloon Occlusion of the Aorta Fly? Assessing Aortic Balloon Performance for Aeromedical Evacuation. J Surg Res. 2020 Oct;254:390-397. doi: 10.1016/j.jss.2020.05.021. Epub 2020 Jun 12. PMID: 32540506.

Morris MC, Kim Y, Blakeman TC, Stevens-Topie S, Jung AD, Cox DB, Robinson BBR, Pritts TA, Makley AT, Goodman MD. Early Identification of Acute Lung Injury in a Porcine Model of Hemorrhagic Shock. J Surg Res. 2020 Mar;247:453-460. doi: 10.1016/j.jss.2019.09.060. Epub 2019 Oct 24. PMID: 31668606.

Baker JE, Goodman MD, Makley AT, Stevens-Topie SM, Veile RA, Mahoney EJ, Heyl JR, Cox DB, Pritts TA, Athota KP. Evaluation of a Novel Fibrin Sealant Patch in Hemorrhage Control After Vascular or Hepatic Injury. Mil Med. 2019 Mar 1;184(3-4):e290-e296. doi: 10.1093/milmed/usy168. PMID: 30007358.

Jung A, Johnson M, Veile R, Friend LA, Stevens-Topie S, Elterman J, Pritts T, Makley A, Goodman M. Variable saline resuscitation in a murine model of combined traumatic brain injury and haemorrhage. Brain Inj. 2018;32(13-14):1834-1842. doi: 10.1080/02699052.2018.1510542. Epub 2018 Aug 23. PMID: 30136863.

Singer KE, Wallen TE, Morris MC, McGlone E, Stevens-Topie S, Earnest R, Goodman MD. Postinjury treatments to make early tactical aeromedical evacuation practical for the brain after TBI. J Trauma Acute Care Surg. 2021 Aug 1;91(2S Suppl 2):S89-S98. doi: 10.1097/TA.0000000000003259. PMID: 33938511.

Thomas Blakeman, Mackenzie Morris, Sabre Stevens-Topie, Michael Goodman, Richard Branson, Dario Rodriquez. Pulmonary Consequences of Harnessing the Thoracic Pump, Respiratory Care Oct 2020, 65 (Suppl 10) 3451052;

Andrew D Jung, MD, Mackenzie C Morris, MD, Rosalie Veile, BS, Lou Ann Friend, RVT, Sabre Stevens-Topie, RVT, Daniel D Cox, MD, Jennifer L McGuire, PhD, Brandon Foreman, MD, Jed A Hartings, PhD, Timothy A Pritts, MD, PhD, Amy T Makley, MD, Michael D Goodman, MD, Vibration Does Not Affect Short Term Outcomes Following Traumatic Brain Injury in a Porcine Model, Military Medicine, Volume 185, Issue 3-4, March-April 2020, Pages e473–e479, https://doi.org/10.1093/milmed/usz346

Jung A, Friend LA, Stevens-Topie S, Schuster R, Lentsch AB, Gavitt B, Caldwell CC. Effect of Fluid Resuscitation Strategy During En Route Care on Acute Lung Injury After Hemorrhage and Burn Injury. Air Force Expeditionary Medical Skills Institute Wright-Patterson AFB United States; 2020 Feb 28.

Baker, J. E., R. M. Boudreau, S. M. Stevens-Topie, M. J. Edwards, E. Gulbins, D. Rodriquez, J. Johannigman, and A. P. Seitz. Antimicrobial Coating Prevents Ventilator-Associated Pneumonia in a 72 Hour Large Animal Model. University of Cincinnati, 2019.

Jung, Andrew D., Mackenzie C. Morris, Rosalie Veile, Lou Ann Friend, Sabre Stevens-Topie, Timothy A. Pritts, Amy T. Makley, Michael D. Goodman, and Daniel Cox. Physiologic Impact of In-Flight Stress Following Traumatic Brain Injury. University of Cincinnati Cincinnati United States, 2019.

Professional Skills and Academic Field Experience Attained Prior to Current Position

Proficient with GAIMS, ELN, Testworks4, Microsoft Office 2003-2013 (Word, Excel, PowerPoint, Publisher), online presentations/webcasting, and various office machinery (copier, fax, scanner, multi-line business telephone, etc.)

Biology and Chemistry Technique Familiarity and Instrumentation: IR and UV/Vis spectrophotometry, pH testing, various assay tests, SNAP tests, electrical charge testing of solutions, serum samples via IDEX, writing laboratory reports, writing grant proposals, electronic scales, chemistry glassware, electrophoresis, DNA sequencing, titrations, various chromatography test types, tissue analysis and identification, mass spectrometry, and various other measuring and identification procedures/testing techniques

Microbiology Technique Familiarity and Instrumentation: Inoculating agar plates, Inoculating broth tubes, using a pipette aseptically, using different sorts of hoods, growth media, growth on selective media, isolating an organism from the environment, plate counts, using spectrophotometer, various microscopes, gram staining, Western Blot, Electrophoresis, and various other biochemical tests)

Proficient Animal Husbandry and Surgical Technique and Pre-Surgical Prep and Post-Surgical Recovery for: Canine, Feline, Avian (General Domesticated Species), Reptile, Pigs, Horses, and Rodent Species (Mice and Rats)

Surgical Technique Proficiency: Catheter placement, intubation, IM injection, IV injection, Vitals Main Line Placement and Monetarization (Electronic), Manual Vital Reading (BPM/RSP), Manual IV setup (Dripline Flow rate), Flow-monitor IV Setup (Electronic), Clamp placement and assistance, closure techniques (staples and suture), dental cleaning, amputation assistance (leg, tail docking, ear crop, declaw removal, hematoma repair on ears), assistance with abdominal exploratory for tumor and organ removal, assistance with necropsy decapitation for rabies validation of cadaver (canine)

Have worked with LIVE LARGE ANIMALS: Cows, Camels, Alpaca, Pigs, Horses, Ducks, Deer, Sheep, Goats, and Mules

Have worked with LIVE SMALL ANIMALS: Canines (Domestic and Wolves), Felines, Rats, Mice, Birds, Snakes, Turtles, Skinks, Salamanders, Groundhogs, Squirrels, Rabbits, Sugar Gliders, Ferrets, and Guinea Pigs

Surgical Techniques on ANIMAL CADAVERS in Academic Setting: Scalpel dissection for anatomy identification and organ extraction (Pigs, Goats, Skates, Stingrays, Cats, Dogs, Sharks, Snakes, Turtles, Rats, Mice, Lamprey, Fish, Birds, Starfish, Hookworms)

Have done species collection and observation (in academic fieldwork situations) with reptiles, amphibians, small rodents, birds, and fish (rough camping wildlife observation trip to Maumee Area on Lake Erie for Great American Bird Count, Brown Trout/macro-species collection sine fishing in Mad River and 4-Mile Creek, behind the scenes work with Cincinnati Zoo in conjunction with vertebrate zoology class, reptile and amphibian collection/health check in various streams in Miami River basin, rodent study with field trapping (rabbits, mice, voles), assist in migration statistics collection for birds)

PROFESIONAL REFERENCES

Darcy Mortimer, PhD RN

Nurse Research Scientist

En Route Care Section

Airman Biosciences Division

Airman Systems Directorate

Air Force Research Laboratory

Email: adx4p0@r.postjobfree.com

Cell: 937-***-****

James B. Lehman, DO-II, USAF

Research Site Lead

En Route Care Section

Airman Biosciences Division

Airman Systems Directorate

Air Force Research Laboratory

Email: adx4p0@r.postjobfree.com

Cell: 830-***-****

T. Chris Blakeman, MSc, RRT (Principal Investigator/Acting Supervisor)

Director of Biomedical and Large Animal Research

Assistant Professor of Surgery

Department of Surgery, Section of General Surgery

University of Cincinnati, COM

Email: adx4p0@r.postjobfree.com

Cell: 859-***-****

Jennifer McGuire, PhD

Research Assistant Professor

Department of Surgery, Section of Neurosurgery

University of Cincinnati, COM

Email: adx4p0@r.postjobfree.com

Cell: 513-***-****

Additional References/Letters of Recommendation

Available upon Request



Contact this candidate