Clinical Research Professional/ Quality Manager

ANTHONY WAYNE SHUPP

**** ********’s Ridge, Hamilton, OH 45011

513-***-**** day • 513-***-**** cell • *******@*******.***

WORK HISTORY

Offering 10+ years of broad and diverse experience in the medical research field. Managed a staff of 20 in a pharmaceutical research clinical environment. Extensive interaction with start-up and well established pharmaceutical companies in procuring, conducting and managing laboratory and clinical trials from Phase I – Phase IV. Demonstrates a broad comprehension of quality control /assurance in a laboratory or manufacturing environment.

PROFESSIONAL CONCENTRATIONS

Good Manufacturing Practices (GMP) Trained ● Good Laboratory Practices (GLP) Trained ● EPA ● OSHA

● Good Clinical Practices (GCP) Trained ● International Organization of Standardization (ISO) ● CAP/CLIA Trained

● Process Development ● New Business Development ● Quality Control/Quality Assurance Methodology

● Regulatory Compliance ● Project Management (PMP) Experience ● ICH Trained ● FDA Regulation

● Standard Operating Procedure (SOP) Implementation ● Process/Product/Study Management ● Process Improvement

EDUCATION & AFFILIATIONS

Bachelors of Science in Biology University of Cincinnati March 1997

Association of Clinical Research Professionals – Member April 2005-Present

QUALIFICATION SUMMARY

• Managed multiple Health Care Professionals (BSN's, RN's, CNA's, phlebotomists, MT's)

• Primary Field Operations Liaison

• Established sequence and precedence of critical work projects and initiate pathways for positive outcome

• Utilized new business development skills to attract 75% of 150 clinical trials conducted by New Horizons Clinical Research

• Implemented new methodology for procedures

• Developed SOP and compliance adherence procedures

• Raised the profit of New Horizons Clinical Research from $250,000 in 2003 to $1,500,00 in 2008 through budget monitoring and supervisory staff management

• Increased the average number of trials per year from 15 in 2003 to 70 in 2008 by effectively leading and managing the clinical research department

• Doubled production on COPD and Asthma trials by utilizing efficient scheduling and logistics techniques

• Researched and designed new experiment protocols for diabetes xenotransplantation projects

• Accelerated batch processing with zero defects recall rate while independently inspecting more than 100 different finished products and over 250 raw materials

• Improved lab analysis testing through research, installation and implementation of automated counting process effectively reducing costs from $26.37 to $3.07 per unit

PROFESSIONAL SYNOPSIS

Cincinnati Children’s Hospital Medical Center

Clinical Trials Office Contract and Budget Specialist 10/2010-present

• Request clinical budget and contract documents from sponsors.

• Review clinical trial protocols and develop internal budgets with principal investigators. Prepare clinical trial budget documents and memos as requested.

• Maintain clinical budget/contract/discount/checklist information in appropriate database.

• Responsible for the set-up of new clinical budget folders.

• Request discounts for clinical study budgets and negotiate budgets with sponsors.

• Coordinate clinical study billing application and pharmacy estimate processes.

• Review clinical trial contracts for routine changes and negotiate Clinical Trial Agreements (CTAs) with sponsors.

• Review consent form for event of injury language as well as examine cost section language against the contract and budget for congruency.

• Draft and edit correspondence, pamphlets, brochures and other documents as necessary.

• Consistently maintain general knowledge of protocols and prepare amendments of budget and/or contracts as required by sponsors.

• Maintain communications with the CCHMC staff and Hospital Billing Departments to ensure accurate coding systems and cost system.

• Coordinate contracts for proper signatories, prepare research checklist packets and circulate for signatures.

• Distribute financial documents to project managers, investigators, and study coordinators.

• Organize the processing of study feasibility questionnaires.

• Perform final accuracy review of contractual documents on a highly time-sensitive basis and assist in the coordination of the signature process.

• Participate in specials projects as requested.

• Communicate verbally and in writing with internal (faculty & staff) and external customers (pharmaceutical companies, governmental entities, organizations) in a cordial, articulate and timely manner.

Community Research

Clinical Research Professional Consultant 7/2010-10/2010

• Research consultation for Phase 1 trial procedures

• Data review of First In Man trials

• Supervision of data release to Sponsor

Lakota/Ross/Fairfield Local Schools

Regional Educator 7/2009-6/2010

• Traveling educator specialized in the areas of Science and Math

• Active support in grades 1 to 12

• Primarily responsible for grades 9 – 12 Honors / College Preparatory classes

New Horizons Clinical Research

Department Manager 1/2003-2/2009

• Primary Field Operations Contact for site

• Supervised all Study Managers and Study Staff from pre-study start up to study close-out

• Procured new business through relationships with pharmaceutical staff contacts and CRO staff

• Trained and educated medical professionals on several levels

• Department staff evaluations

• Experience in departmental budgeting and contract negotiations

• Proficient with several varieties of Electronic Data Capture systems

• Extensive data monitoring and review for in-house quality control and regulation adherence

• Liaison with business partners to ensure alignment and direction of project

• Department oversight for Data Procurement, Data Review, Data Monitoring, Data Corrections

• Proficient in Phlebotomy, Lab Processing, ECG, Aseptic Technique, PFT, Nursing Procedures

• Senior Clinical Research Coordinator

COPD, Asthma, CAD, Hypertension, Diabetes, Gout, Oncology, Hyperlipidemia, Hypercholesterolemia, OA, Pain

Study Procurement through site/CRO/Study Sponsor negotiations, main IRB contact, primary associate for site initiations, patient recruitment/retention, study start-up leader, coordinator procedures, EDC specialist, key study contact, initial study close out associate for all studies, SAE & AE reporter/follow-up/completion, FDA contact for audits, pre-FDA auditor

The Rogosin Institute

Laboratory Manager 10/2001-12/2003

• Managed 5 study staff in the post retrieval macro beads and pancreas sample laboratory

• Oversaw the quality control process for the Diabetes Research Department

Research Associate 1/2001-9/2001

• Conceptualized and designed a new biomedical product in order to advance an alternative for diabetic treatment

• Created SOP’s and protocols for islet collection and macro bead encapsulation

• Developed statistical sampling process for diabetic research

• Extensive product knowledge and clinical application of product for the Diabetes Research Department

Avon Inc.

Laboratory Manager 7/2000-12/2000

• Managed 10 processing staff in completion of finished product

• Provided final approval for team’s release of product to market

Laboratory Associate 1/2000-6/2000

• Regulated and tested batch specifications of raw and finished products

• Educated in quality, compliance and regulation in order to produce a compliant, safe, effective and market-ready product

• Supported product development efforts by preparing and reviewing verification/validation processes

• Provided final approval for team’s release of product to market

• Maintained a strong level of detail orientation in calibration of laboratory equipment and standardization of solutions

• FTIR, UV-VIS spectrophotometry, GC, HPLC, pH testing, physical testing, wet chemistry, color and odor testing

Miller Brewing Company

Laboratory Technician 1/1999-12/1999

• Conducted filtration testing, culture analysis and sample collection to detect microbiological growth

• Performed uniformity testing among all Miller breweries to ensure taste conformity

• Achieved 100% product purity which resulted in the laboratory distinction of Best Efficiency Brewery in the World

Bethesda North Hospital

Emergency Department Technician 1/1997-12/1998

• Performed orthopedic and phlebotical procedures

• Provided patient assessment for doctors and nurses

• Assisted in all trauma care

Mercy North Hospital

Emergency Department Technician 11/1994-12/1996

• Performed orthopedic and phlebotical procedures

• Provided patient assessment for doctors and nurses

• Assisted in all trauma care

Surgical Background

Surgical Shadowing of Physicians 1993-1999

Shadowed Dr. Paul Cangemi and other physicians on over 100 surgical cases at Mercy North, Mercy South and Ft. Hamilton Hospitals. Observance of multiple surgical techniques and procedures. Trained in areas of sterile environment and equipment. Observation of clinical staff interaction for optimal results. Knowledge of hip and knee replacements, cyst removals, shoulder manipulations, ACL repairs, PCL repairs, meniscectomies, tibia/fibula repair, Tommy John surgery, radius/ulna repair and other general laproscopic procedures.

TECHNICAL BACKGROUND

MS Excel • MS Word • Access • Powerpoint

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