Deb Mitchell Odessa, MO 64076

ddzlmitchell@gmail.com 816 565 2077

OBJECTIVE To obtain a position to utilize my vast ophthalmic and clinical research experience, as

well as my exceptional leadership and organizational skills. SUMMARY

• Over 28 years’ experience in the Health Care field. • Extensive display of ability to multi-task, quickly grasp complex concepts and skills, and

function in a fast-paced work environment as a Certified Ophthalmic Technician, Start-up Specialist and Clinical Trial Assistant in the field of clinical research.

• Responsible for training clinical staff and ophthalmic technicians in both large group and individual settings.

PROFESSIONAL EXPERIENCE August 2012 to Present Quintiles Overland Park, KS

Sr. Clinical Trial Assistant

• Work on Phase I-IV studies • Application of functional base of knowledge regarding the application of GCPs, ICH

guidelines, applicable regulatory requirements and SOPs and Work Instructions to assigned responsibilities

• Lead the contract amendment team • Assist Clinical Project Manager (CPM) and Clinical Research Associates (CRAs) with

accurately updating and maintaining clinical systems that track site compliance and performance within project timelines

• Collaborate with clinical team to prepare, manage, distribute, file and archive clinical documentation and reports according to the scope of work and SOPs. Assist with periodic review of study files for accuracy and completeness.

• Collaborate with clinical team to prepare, manage, and distribute the Clinical Trial supplies and maintain all tracking information.

• Mentor and train clinical staff individually or project teams.

September 2011 to August 2012 Quintiles Overland Park, KS

Site Start-Up Lead

• Worked on over 50 protocols for multiple sponsors • Prepared contract and budget amendment templates for the amendment team • Reviewed and negotiated contract and budget amendments with the investigational

sites/institutions • Collaborated with the legal department for complex matters

August 2006 to September 2011 Quintiles Overland Park, KS

Site Start-Up Specialist

• Worked on Phase I-IV studies • Reviewed and/or negotiated regulatory documents, contracts and budgets as required for

site initiation; contacted sites as required to resolve issues; and determined completeness and readiness for Clinical Supplies/Investigational Product shipment

• Managed data tracking entries into designated clinical tracking systems in accordance with project requirements

• Assisted designated team members with preparing submissions for Independent Ethics Committees (IEC) or Institutional Review Boards (IRB), by compiling and submitting the documentation packages.

• Application of functional base of knowledge regarding the application of GCPs, ICH guidelines, applicable regulatory requirements and Quintiles and Sponsor SOPs and Work Instructions to assigned responsibilities

• Provided quality assurance testing and training on new computer systems.

Sept. 2005 to May 2006 Sabates Eye Center Kansas City, MO

Certified Ophthalmic Technician / Study Coordinator

• Worked as a study coordinator on various Phase II-IV studies • Completed essential regulatory documents • Completed all local IRB submissions for new protocols, amendments, SAEs, and annual

reviews • Responsible for completion of CRFs and inputting the data in the Inform and PDS

systems • Performed all study-specific ophthalmic testing including patient history, visual acuity,

manual refractions, application tonometry, visual fields, OCT, fluorescein angiograms, and fundus photography

June 1998 to May 2005 Silverstein Eye Centers Kansas City, MO

Certified Ophthalmic Technician

• Performed all ophthalmic tests including patient history, visual acuity, manual refractions, application tonometry, visual fields, OCT, GDX, fluorescein angiograms, fundus photography, A-scans, B-scans, and scribing

• Counseled patients for all ophthalmic surgeries • Trained new technicians in all aspects of job responsibilities

CLINICAL RESEARCH EXPERIENCE

Project description

Responsibilities/Tasks

Phase Indication I Oncology – Multiple Protocols Sr. Clinical Trial Assistant III Diabetes Sr. Clinical Trial Assistant II Non-Alcoholic Steatohepatitis Sr. Clinical Trial Assistant

IV Rheumatoid Arthritis with Cardio Vascular Events

Sr. Clinical Trial Assistant

III Flu Vaccine – Multiple Protocols Clinical Project and Site Startup Specialist II Major Depressive Disorder Clinical Project and Site Startup Specialist III Toenail Fungus Clinical Project and Site Startup Specialist I Food Effect Clinical Project and Site Startup Specialist I PET Scan Clinical Project and Site Startup Specialist II/III Pneumonia Clinical Project and Site Startup Specialist IV Insomnia Clinical Project and Site Startup Specialist

III COPD – Multiple Protocols Clinical Project and Site Startup Specialist II Respiratory Tract Infection Clinical Project and Site Startup Specialist III Asthma in minors Clinical Project and Site Startup Specialist III Asthma – Multiple Protocols Clinical Project and Site Startup Specialist

I Rheumatoid Arthritis – Multiple Protocols

Clinical Project and Site Startup Specialist

III COPD/Asthma Clinical Project and Site Startup Specialist

III CNS/Psychiatric – Multiple Protocols

Clinical Project and Site Startup Specialist

IV Diabetes Clinical Project and Site Startup Specialist II Oncology Clinical Project and Site Startup Specialist III Allergic Rhinitis Clinical Project and Site Startup Specialist III Crohn’s Disease Clinical Project and Site Startup Specialist III Ulcerative Colitis Clinical Project and Site Startup Specialist

III Attention Impairment in Children Following Cancer Treatment

Clinical Project and Site Startup Specialist

III Ragweed Allergy Clinical Project and Site Startup Specialist II/III Anti-Infectives Clinical Project and Site Startup Specialist IV Diabetes Clinical Project and Site Startup Specialist I Macular Degeneration Clinical Project and Site Startup Specialist

III

Active Immunization against influenza disease caused by influenza virus A subtypes and B types

Clinical Project and Site Startup Specialist

III Constipation – Multiple Protocols Clinical Project and Site Startup Specialist

II/III Age Related Macular Degeneration – Multiple Protocols

Ophthalmic Technician & Assistant Study Coordinator/Sabates Eye Center

III/IVb Age Related Macular Degeneration – Multiple Protocols

Ophthalmic Technician & Assistant Study Coordinator/Sabates Eye Center

Various IntraOcular Lens Implants Ophthalmic Technician / Silverstein Eye Centers Various Ocular Allergy Drops Ophthalmic Technician / Silverstein Eye Centers

EDUCATION

1988 – Blue Springs Community College – Attendee 1986 – Blue Springs High School – Graduate

LICENSES AND CERTIFICATIONS

• April 2014 – Barnett Accreditation – Fundamentals GCP exam for Managers and Staff interacting with investigational sites

• May 2012 – Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational Sites

• April 1997 – JCAHPO Certified Ophthalmic Technician (certification was not renewed after continuing career in clinical research; approximately 2007)

AWARDS AND HONORS

Received 70 Work Worth Doing Awards from the Quintiles recognition program. The program is designed to highlight the excellence that exists in all areas and job functions across Quintiles. The awards are for teamwork, leadership, customer service and quality.