Guy A. Stehley

**** *. ******** ***.

Chicago, IL 60640

312-***-****

adt7xg@r.postjobfree.com

THERAPEUTIC-AREA EXPERIENCE

● Oncology - 8 years

● Central Nervous System - 7 years

● Anesthesiology/Sedation - 5 years

● Sets and Devices - 3 years

● Gastroenterology - 3 years

● Nephrology/ESRD - 3 years

● Dermatology - 2 years

● Orthopedics - 2 years

● Infectious Diseases - 2 years

● Pain Management - 2 years

● Rheumatology (Lupus) - 2 years

● Hypertension - 2 years

● Asthma - 1 year

● Vaccines (Influenza) - 1 year

● Cardiology - 1 year

● Phase 1 - 3 years

● Phase 2 - 15 years

● Phase 3 - 15 years

FDA-APPROVED DRUGS/DEVICE - INDICATIONS

● Prevacid (Lansoprazole) - reflux, Barrett’s Esophagus, Zollinger-Ellison Syndrome

● Soltamox (Tamoxifen) - breast cancer

● Ultane (Sevoflurane) - inhalation anesthesia

● Namenda (Memantine) - Alzheimer’s disease

● Precedex (Dexmedetomidine) - neonatal sedation

● Zemplar (Paricalcitol) - ESRD (End-Stage Renal Disease)

● PLUM Electronic IV Pump

RELEVANT EXPERIENCE - OTHER

● ICH-GCP (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practices) and CFR (Code of Federal Regulations) - 25 years

● CAPA (Corrective and Preventive Action) - 20 years

● EDC – (Electronic Data Capture) - 10 years

● EMR (Electronic Medical Records) - 3 years

● GMP (Good Manufacturing Practices) - 2 years

EMPLOYMENT HISTORY

Barrington James Life Science Recruitment Firm

New York, NY October 2019 - January 2020

Remote Visit Associate (short-term contract)

● Recruited and contracted homecare agencies and independent homecare providers on multiple projects

● Designed homecare training materials

● Trained homecare providers in study-specific procedures

● Coordinated in-home study visits with homecare providers and study patients pg. 1

Sarah Cannon Research Institute

Nashville, TN Nov 2016 - Jun 2018

Senior Clinical Team Lead

● Planned and tracked all assigned clinical activities for site evaluation, start-up, initiation, interim monitoring and close-out processes

● Managed project-resource needs and project-related issues and communicated deviations from projections and proposed solutions to the appropriate management level

● Assisted CPMs (Clinical Project Managers) with creation and maintenance of project documents and plans

(i.e., Visit Report/Letter Templates and Monitoring, Communication and Recruitment Plans)

● Worked directly with data management to monitor site accrual and data retrieval

● Supervised and tracked trial enrollment, serious adverse events, protocol deviations, violations and trends and addressed study inquiries and site issues

● Proposed improvements and tools to CEO to enhance the efficiency and the quality of research

● Developed status reports and communicated with all applicable teams

● Initiated improvements to enhance the efficiency and quality of the work performed on assigned projects

● Conducted CRA, sponsor and team meetings as delegated by the CPM

● Attended project meetings, conference calls and monthly staff meetings, as required

● Conducted quarterly on-site Quality Control/TMF (Trial Master File) audits

● Tracked, reviewed and approved monitoring visit reports and follow-up letters

● Adhered to professional standards, ICH-GCP Guidelines and corporate SOPs Chiltern US

Wilmington, NC Oct 2015 - Nov 2016

Senior CRA (short-term contract)

● Prepared and conducted qualification, initiation, monitoring, motivational, audit support and close-out site visits for Oncology trials

● Ensured that site files were assembled prior to release of clinical supplies and tracked and filed study-related communication

● Tracked patient recruitment

● Managed local and/or central laboratories

● Facilitated the preparation of Ethics Committee (EC)/IRB submission documentation and updated ECs/IRBs regarding protocol amendments, SAEs, interim safety reports, etc.

● Distributed and tracked clinical trial supplies

● Authored and reviewed Diary Cards, eCRFs and other patient-related data capture tools

● Tracked CRFs and queries from review to collection to submission to data management

● Ensured that all relevant study documentation was present for study sites

● Documented all study activities including investigator contacts

● Organized and presented at study meetings

ICON Clinical Research

Chicago, IL May 2013 - Oct 2015

Senior CRA

● Identified and selected investigational sites for Dermatology, Non-Small Cell Lung Cancer, Kidney Dialysis and Influenza Vaccine studies

● Conducted pre-study, initiation, monitoring and close-out visits

● Reconciled TMFs

● Managed studies and trained staff

● Provided benchmark of monitoring competence to less experienced colleagues pg. 2

GlobalCare Clinical Trials

Bannockburn, IL May 2012 - May 2013

CPM

● Managed international ALS and domestic Dermatology trials

● Conducted on-site initiations and ongoing remote monitoring of homecare nurses, data and study equipment

● Supervised five CRAs

● Reconciled TMFs

Covance, Inc.

Princeton, NJ Jul 2011 - May 2012

Senior CRA (short-term contract)

● Conducted pre-study, initiation, monitoring and close-out visits for Influenza studies

● Reconciled TMFs

● Prepared accurate and timely trip reports

● Ensured that site staff received required materials and instructions to safely enroll and protect subjects by verifying consenting procedures and protocol requirements and the integrity of data Hospira, Inc.

Lake Forest, IL Aug 2009 - Jul 2011

CPM

● Directed CRO, CRAs (10), laboratory, data management and statistics for successful international, pivotal Phase III Neonatal Sedative (Dexmedetomidine - Precedex) trial

● Supervised all study start-up/site-activation endeavors

● Negotiated study budgets

● Met all deliverable timelines

● Operated within budget

● Organized Investigators’ Meeting (Central America), including preparing, facilitating and presenting

● Trained PIs, Study Coordinators and CRAs

● Performed initiation, monitoring and site motivational visits

● Provided accurate projections, reports, updates and ongoing risk assessments directly to VP/Medical Affairs, including scheduling and hosting cross-functional team meetings

● Initiated 1300-subject Glucose-Monitoring device trial

● Revised/authored global SOPs per ICH-GCP Guidelines Abbott Laboratories

Abbott Park, IL Feb 2006 - Aug 2009

Lead CRA (contract)

● Monitored Respiratory (Asthma) and Phase 1/Pharmacology Pain trials

● Guided two co-monitors in retrieving Phase 1/Pharmacology data with minimal queries and met all critical-path timelines

● Reviewed, revised and developed/authored CRFs and protocols

● Performed drug accountability

● Maintained critical documents and reconciled Trial Master Files

● Initiated clinical research training program for administrative assistants Forest Laboratories

Newark, NJ May 2003 - Feb 2006

Senior CRA

● Regionally monitored CNS (Major Depressive Disorder, Alzheimer’s Disease, Schizophrenia) clinical trials

● Conducted initiation, monitoring and close-out visits

● Performed drug accountability

● Reconciled trial master files

pg. 3

TAP Pharmaceuticals/Abbott Laboratories

Bannockburn and Abbott Park, IL Mar 1990 - May 2003 CPM/Senior CRA/CRA

● Developed and directed CRA Mentoring Program

● Hired, trained and managed seven contract CRAs

● Recruited 12 investigators

● Monitored Phases 1, 2 and 3 trials in the following therapeutic areas: Breast Cancer, Peptic Ulcers, Barrett’s Esophagus, Zollinger-Ellison Syndrome, Inhalation Anesthesia, Hyperparathyroidism, Orthopedic Infectious Disease, Chronic Pain, Lupus and Drug-Eluting Cardiac Stent

● Conducted evaluation initiation, monitoring and close-out visits

● Performed drug accountability

● Reconciled trial master files

● Liaised with Central Laboratory

● Developed CRFs and authored protocols and study reports Abbott Laboratories

North Chicago and Abbott Park, IL Jul 1980 - Mar 1990 Chemist/QA Supervisor/Medical Writer/CRA

● Performed standard chemical reactions in antihypertensive-drug synthesizing

● Supervised 13 QA technicians in Abbott’s Hospital Products Division

● Authored protocols and study reports

● Designed CRFs

● Recruited investigators

● Wrote abstracts and copy for package inserts

● Responded in writing to requests for marketed product information (Medical Communications)

● Generated drug experience reports and literature reviews

● Conducted initiation, monitoring and close-out visits for Device and Antihypertensive studies

● Reconciled Trial Master Files

EDUCATION

College of Lake County

CNA

Lake Forest College

BA, Chemistry/Biology

COMPUTER SKILLS

● Word, Excel, PowerPoint

● Electronic Data Capture - EDC (DataLabs, DataTrak, InForm, MediData) pg. 4

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