Jeffrey A. Stevens BHS. RT(R)(MR)

**** **** **** **. **. Louis, Missouri 63011

adyhrv@r.postjobfree.com

314-***-****

ACADEMIC PREPARATIONS

Bachelor of Health Science in Radiologic Technology, University of Missouri-Columbia, Columbia, MO. Aug 1987

ARRT registered Radiologic Technologist with sub-specialty in MRI.

LISCENSES AND CERTIFICATIONS:

Registered Radiologic Technologist 1987 AART #221279

Advanced registry in Magnetic Resonance Imaging

Yellow Belt Lean Six Sigma Certification November 2010

ASRT membership

IMAGING ENDPOINTS LLC, Scottsdale, AZ (Remote)

Imaging Project Manager February 2022 – Current

Project Management Experience Reads Types

Phase III Glioblastoma study

RECIST 1.1 RANO-BM

Phase I/II r/r Non-Hodgkin Lymphoma and r/r B-Cell Acute Lymphoblastic Leukemia

RANO

Phase I/II/III Gene Transfer for the Treatment of Wilson Disease

Lugano

Phase II BRAF class 1 and class 2 cancer harboring BRAF alterations

RANO-BM

RANO-HGG

RANO-LGG

Phase I/II Safety and Efficacy of Mediated Gene Therapy for Subjects with Type 1 Gaucher Disease

RECIL

Bone Marrow Burden (BMB)

Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines.

Manage day-to-day operational aspects of clinical imaging projects.

Assist in preparation and adherence to imaging trial documents, Image Review Charter, Imaging Manual, Data Transmittal Forms, site training slides and site evaluation questionnaires.

Ensure project documents are complete, current, and stored appropriately.

Manage key project documents/processes, i.e., Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan, and appropriate Clinical Trial Management System (CTMS)

Identify resources needed and assign individual responsibilities.

Identify out of scope requests and work with appropriate team(s) to revise the work to meet changing needs and requirements.

Review and manage all deliverables.

Prepare metrics reporting for client and senior management.

Prepare forecasting information for Finance purposes.

Perform other duties as assigned by the Supervisor.

Green Tree Home Solutions, Edwardsville, IL

Field Manager March 2015 – February 2022

Developed Authored estimates for insurance and large retail bids.

Trained new sales staff on selling program and general onboarding.

On site claim assessment execution

Utilized CRM for sales, production to enter and process claim details.

Produced claim estimates for supplemental insurance claims.

Postproduction quality assurance of completed retail and insurance projects.

Managed and developed relationships with supply vendors.

Led project specific meetings with adjusters, built professional relationships across multiple carriers.

Conducted detailed audit reports and provided comprehensive action plans.

Responsible for implementing inside sales training for all sales representatives for residential in-home sales

Biomedical Systems, St. Louis, MO

Project Manager, October 2013-April 2015

Project Management Experience Technical Experience

Phase III Oncology study RECIST 1.1

GE SIGNA MRI Scanners: 0.3T. 1.0T 1.5T

Natural History HPP

GE Lightspeed multi-slice CT scanners

3 MLD studies: Phase I/II and Natural History

GE Digital R/F rooms

Spinal Stabilization device pivotal vs. investigational

Portable Fluoroscopy

Phase I/II Safety, Tolerability, Pharmacokinetics Anti-Tumor Activity Study

Toshiba Aquilion CT scanners

Breast Ultrasound device

Hitachi Altaire 0.7T, Oasis 1.2T MRI scanners

Medrad Power Injectors

GE PACS

Job Duties:

Management of imaging protocols of global clinical trials.

Design and writing of Imaging Service Review Charters, Independent Review Manual, Site Procedure and Core Lab Manuals.

Manage sites/imaging centers; provide critical analysis as to the capability of a center to perform required imaging related procedures for a clinical trial. Provide critique analysis on quality of data obtained.

Advise imaging centers on ensuing issues that arise during required procedures, while making evaluations/recommendation on discontinuance of the center’s participation with the clinical study

Follow guidelines with Good Clinical Practices and internal Standard Operation Procedures. Reviews patient image data for diagnostic quality, prepares image data for analysis and expert review as required by the FDA.

Assist in the design of the imaging and efficacy portions of the clinical protocols as well as the Expert Review protocol.

Provide analysis as to the practical design of imaging procedures and design of quantifiable efficacy endpoints. Write and implement the Expert Review procedures, design the randomization procedure to best display image data for obtaining the primary efficacy endpoint data. Work with data management to design case report forms for this process.

Attend Investigator meetings and present protocol related image processing. Present the process and procedures for image data acquisition and archival to investigator and study coordinators. Serve as an expert panelist to answer questions on the efficacy of design and imaging procedures.

Contract negotiations to obtain physicians as independent reviewers, experienced with training physicians on the review process and associated computer software.

Achievements:

Per sponsor request generated Mitigation plan to reduce data reporting errors.

Developed new quality control procedures on incoming data to prevent data errors to sponsor.

Created Root Cause Analysis plan to identify causes of errors in data sent to sponsor.

Decreased error reporting rate to sponsor from over 1.7% to zero errors.

Regained the confidence of the sponsor due to my professionalism.

Biomedical Systems St. Louis, MO

Medical Imaging Specialist December 2012-October 2013

Provide technical assistance to the study centers for issues relating to submitted image data and provide solutions.

Assist Project Manager in preparation of the study specific documents and manuals.

Provide assistance in the shipment of documents and/or image material to the study centers.

Assist in the development of departmental Standard of Operating Procedures

Provide image assurance evaluations of imaging and document data for analysis and expert review as required by the FDA.

Provide critical analysis as the capability of a center to perform the required tasks for each specific imaging protocol.

Assist with BICR read and support.

Provide expert analysis of MRI/MRA imaging protocols.

Blinding, editing, digitizing, and preparing imaging data prior to importation into study specific databases.

Initiate and track queries to the study centers. Provide support to the study centers with questions regarding query issues.

St. Anthony’s Medical Center, St. Louis, MO

Director of Outpatient Imaging, February 2008- October 2012

Responsible for day-to-day operations of two outpatient imaging centers with a 25M Gross budget

Created superior customer service scores for 16 consecutive quarters as measured by patient surveys.

Capital improvement project management for 2 MR and 2 CT scanners and a DICOM CD burning solution for the imaging centers and hospital radiology departments.

Implemented POS creatinine testing for patients receiving IV contrast material for CT/MRI procedures. This reduced delays and increased the operating budget.

Developed tracking program by collaborating with the finance department to view specific referral patterns from subspecialty physicians to help define the marketing program.

Worked with Physician Relations Executives with on-boarding of new physicians to the medical center.

Provide oversight of front office operations and all technical staff. Completed annual performance appraisals and developed performance improvement plans.

Visited referring physicians to build relations and to foster a team approach by being an extension of their office for patients imaging needs.

Provided QA/QC for the four Urgent Care facilities regarding radiographs.

Center for Diagnostic Imaging, St. Louis, MO

Senior Chief Technologist, June 2003-February 2008

Reported to Vice President of Operations, consulted on financial/marketing decisions for multiple imaging centers in the local market.

Interacted with Medical Director to optimize imaging protocols.

Local resource point of contact for all IT issues and systems connectivity.

Trained physicians on RIS and PACS systems, provided remote access to workstations to provide rapid resolutions to technical workstation problems.

Participated in staff performance evaluations, compensation recommendations and developed performance improvement plans.

Responsible for the hiring of all technical staff and maintained superior customer satisfaction as measured by independent patient surveys.

Responsible for all imaging protocol development at each imaging center.

St. John’s Mercy Medical Center, St. Louis, MO

MRI/CT Technologist, August 1987- June 2003

Extensive clinical experience in a level I hospital in a suburban setting.

Intra-operative radiographic/fluoroscopic procedures.

Clinical experience with GE SIGNA 1.0/0.3 and 1.5T MRI scanners

Clinical experience with GE 9800 Highlight single slice scanner, Technicare 1440 and GE 8800 CT scanners

Intrauterine fetal imaging

DCE studies of the head/neck/aorta/abdomen/extremities

Medrad dual head power contrast injectors

Mastery of imaging protocols of the head/neck, chest, abdomen, extremities for adults and pediatrics.

Inpatient/outpatient/emergency room/operating room patients in a fast-paced high-pressure environment.

Maintained excellent customer service as documented by letters written to supervisor stating how a pleasant experience was achieved by my attention and instructions.

Implementation team member for Patient Focused Care role out to entire medical center

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