Customer Service Medical

LORRIE M. MILLS

Tempe, AZ ***** C: 480-***-**** **********@*****.***

Profile

Dedicated Research Professional with excellent technical, analytical and communication skills

demonstrated by 20+ years experience in medical and research industries. Experience includes

management of 100+ Clinical Trials for a wide variety of therapeutic areas for Phase I - Phase IV Trials

with a firm understanding of the desired study end-points and goal. Established credibility and a strong

presence with internal and external partners showing strong leadership skills, excellent customer service

and maximal productivity. Proficient in multi-tasking with proven ability to meet aggressive timelines and

overcome challenges with a positive and energetic demeanor.

Therapeutic Areas of Expertise

• •

Cardiology/Vascular Diseases Oncology

• •

Dermatology Ophthalmology

• •

Endocrinology Orthopedics/Orthopedic Surgery

• •

Family Medicine OTC Studies

• •

Gastroenterology Pain Management

• •

Geriatrics Pediatrics

• •

Hematology Podiatry

• •

Immunology Psychiatry/Psychology

• •

Internal Medicine Pulmonary/Respiratory Diseases

• •

Medical Devices Sleep Disorders

• •

Musculoskeletal Surgical Studies

• •

Nutrition and Weight Loss Urology

• •

Obstetrics/Gynecology (Women’s Health) Vaccines

Skills

• Superior research knowledge in • Thrives in high-demand, fast-paced

pharmaceutical, device and surgical studies environments

• Regulatory compliance • Team player with positive attitude

• Contract negotiation/review/drafting • Methodical critical thinking, reasoning and

• Cost reduction and containment problem solving

• Self-starter, organized, proactive

• Process improvement

• Curriculum development and assessment

• Recruiting

• Facilitator of clinicaltrial.gov

• Training and development

• Paper and electronic data capture

• Interpersonal, oral, written communication

• Special emphasis on understanding and

and organizational skills

• Strong work ethic, adept multi-tasker compliance of HIPPA, FDA, GCP, GMP,

IRB, ICH, World Health Organization

• Exceptional time management skills

(WHO), SOP guidelines and regulations

• Understands various learning styles

• OSHA, JHACO, State inspections

Accomplishments

Auditing

• Extensive review, compilation of research and medical records for IRB, FDA and IRB audits,

reviews, compilations and audits for Governmental organizations resulting in 100% approval rating

Customer Service

• Handled customers effectively by identifying needs, quickly gaining trust, approaching complex

situations and resolving problems to maximize 100% efficiency

• Saved 20% in supply costs by renegotiating vendor contracts

LORRIE M. MILLS

Tempe, AZ 85281 C: 480-***-**** **********@*****.***

Process Improvement

• Created clinical workshops targeting research coordinators to create an engaging educational

experience for effective and efficient study conduct reducing data errors by 60%

• Implemented an internet recruitment module to streamline recruitment for investigative sites

increasing enrollment by 15%

• Liaised with co-workers to modify and improve overall clinical research performance by

developing process improvements for research procedures and projects

• Developed & delivered inter-departmental training modules and manuals that resulted in increasing

new employee operational effectiveness by 80%

Project Management

• Supervised project production efforts to ensure projects completed to company standards, on-time

and within budget constraints

• Rolled out 3 new company products annually, resulting in positive revenue growth

Testing, Evaluation and Statistical Analysis

• Performed data collection and statistical analysis review resulting in sound recommendations that

were adopted by R&D department for clinical study reports submitted to FDA resulting in 100%

FDA product approval

• Researched, tested, provided recommendations and implemented clinical trial management systems

to ensure 100% compliance for study data confidentiality, collection, storage and transparency of

research data throughout cross-functional team

Professional Experience

Medicis Pharmaceutical Corporation 03/2005 – 12/2012

Sr. Clinical Trial Coordinator Scottsdale, AZ

• Project Oversight and Leadership for Clinical Deliverables

• Responsible for in-house management of multiple complex Phase I - IV drug & device clinical

research studies

• Planned and lead execution of the day to day activities for the monitoring of clinical studies and

consistent communication with the clinical team providing project objectives, expectations and

status updates

• Collaborated with Project Manager (PM) to facilitate cross functional team and sponsor

communication for proactive, study-wide problem solving regarding study progress and trial issues

• Identified opportunities to improve training, execution and quality control across the department

• Created and maintained project specific plans, documents and tools for the clinical team

• Supported Clinical Research Associates (CRAs’) with site monitoring activities and provided

suggestions and solutions to site issues where applicable

• Co-monitored investigator sites as needed performing source verification, CRF collection,

regulatory binder and related study records review

• Liaison for clinical monitoring issues, interacting with clients, and vendors, escalating as required

LORRIE M. MILLS

Tempe, AZ 85281 C: 480-***-**** **********@*****.***

• Organized project specific compliance plans for key processes, tools and systems

• Demonstrated ability to problem-solve and anticipate issues that may arise in clinical trials and take

efficient, effective, and appropriate actions

• In-depth working knowledge of protocols, clinical practices, and training requirements. Prepared

custom designs and developed clinical start-up plans, Diaries, CRFs, Source Documents,

Regulatory, and Reference manuals for clinical research studies within designated timelines and

budgetary restraints

• Provided guided review, approval, and feedback on protocols, amendments, informed consents,

CRFs, monitoring plans, scope of work changes, site and vendor directives and any other study

related documents

• Responsible for review of Clinical Study reports prior to FDA submissions

• Committed team player helping out wherever needed to best serve departmental and corporate

objectives, goals and establish clear strategic objectives to achieve desired metrics for R&D

Department

• Drafted requests for proposals and statements of work with multiple investigators and vendors

• Worked with cross functional resources to implement Documentum program reaching a 100%

increase in data sharing company wide

• Managed projects and served as primary liaison between client and multiple internal groups to

ensure clarity of goals, quality and adherence to deadlines

• Member of SOP committee - developed SOPs for R&D Department as appropriate and revised

existing SOPs as necessary

• Complied with IRB, federal, state, local and company policies, procedures and regulations

• Submitted essential study documents to IRB on behalf of the sponsor and investigator sites for

approval consideration and maintained IRB communication and approval throughout clinical trial to

close-out

• Developed metrics to determine inefficiencies and identified areas for improvement for clinical

research department by documenting process flows for functional improvements and enhancements

• Defined the scope and goal of new projects, including pharmaceutical and device study projects

• Identified issues with existing marketing material to drive process improvements for study

enrollment

• Prepared monthly finance reconciliations, forecasts and expense reports for Program Management

and Finance Departments for evaluation of study budget performance

• Offered feedback to executive-level management on the effectiveness of strategies, design and

initiatives for potential new clinical programs

• Liaised with investigators, coordinators and site study team to conduct trials

• Developed training manual for new staff to ease transition of new employees into department

LORRIE M. MILLS

Tempe, AZ 85281 C: 480-***-**** **********@*****.***

• Accurately utilized Redline format to draft and review General Counsel Agreements with

Investigators and Vendors

• Designed media advertisements, including TV, radio, print and digital for clinical trial recruitment

• Boosted company efficiency through technology upgrades and process improvements for clinical

trial management system and Documentum

• Designed new storage area by maximizing the space capacity resulting in reducing off-site storage

cost by $10K monthly

Arizona Arthritis & Rheumatology Associates 07/2004 – 02/2005

Clinical Trial Coordinator Paradise Valley, AZ

• Managed numerous Phase II – Phase IV clinical research projects simultaneously within study

timelines and budgetary restrictions

• Responsible for overseeing and organizing all aspects of medical/pharmaceutical research projects

including recruitment, collecting research data, troubleshooting, filing, reconciling discrepancies

and archiving

• Ensured compliance with medical/legal/regulatory requirements with IRB, federal, state and local

regulations

• Designed and developed study related documents and tools for increased proficiency of data

collection for clinical trials

• Liaison with CRAs’ for data review of clinical trials eliminating discrepancies resulting in clean

data collection

• Extensive medical records review for disease confirmation for prospective study participation

• IRB Submissions and maintenance

Arizona Research Center 02/2004 – 07/2004

Clinical Trial Coordinator Phoenix, AZ

• Managed multiple hospital surgical clinical research studies in accordance with applicable federal

regulations, ICH, GCP, company SOPs, multiple hospital SOPs, JCAHO, state, local, central and

local IRB guidelines, restrictions and regulations

• Ensured compliance with medical/legal requirements per protocol and hospital policies

• Created templates and tools to enhance data capture requirements per sponsor specifications

• Facilitated resolutions for query discrepancies by collaborating with CRA’s, data management and

sponsors

• Maintained and managed study data environment including troubleshooting, filing and archiving

• Routinely performed medical laboratory tests, procedures, and analyses to provide data for clinical

research studies

• Expertly managed all surgery services, including planning, scheduling and coordination,

determination of procedures and procurement of supplies and equipment for clinical research study

LORRIE M. MILLS

Tempe, AZ 85281 C: 480-***-**** **********@*****.***

• Monitored post-op vitals, distributed study medication, reviewed post-op orders, hospital records,

surgical reports and oriented patients to unit per protocol requirements

Radiant Research 01/1999 – 02/2004

Clinical Trial Coordinator Scottsdale, AZ

• Managed multiple Phase II – Phase IV clinical trials for numerous sponsors simultaneously from

start-up to close-out within sponsor requirements and restrictions

• Collaborated with multiple sponsors to review protocols, CRF design and document development

per protocol compliance

• Designed and created tracking tools and checklists for multiple clinical research projects

• Designed source documents per protocol to capture required data points per sponsor specifications

• Developed and organized study records and maintenance reports for increased efficiency

• Reduced data verification times by 50% by inventing a new drug accountability system

• Assessed and re-designed facility plans based on department growth requirements and revised

business model for floor plans for exact specifications and dimensions utilizing space effectively

and efficiently

• Routinely performed medical laboratory tests, procedures, and analyses to provide data for clinical

research studies

• Developed highly empathetic client relationships and earned reputation for exceeding company

customer service policy

Additional Experience 03/1985 – 01/2004

• Managed 20 medical staff employees for a busy 6 physician medical office for Scottsdale

Healthcare Hospital - Family Practice Division

• Responsible for hiring, firing and managing back-office physicians & staff schedules and duties.

Evaluated employee performances, and developed SOPs for policies and procedures for the medical

office practice per FDA, state and local authorities, JCAHO and hospital SOPs

• Reduced cost by 20% by initiating vendor agreements to negotiate cost containment of medical and

pharmacy supplies

• Developed procedure manual for medical processes and procedures for 14 Scottsdale Healthcare

Family Practice sites

• Fluent in HIPPA Laws, JCAHO & OSHA Regulations, GCPs, GMP’s and FDA Guidelines

including health insurance requirements and authorizations, billing and reconciliations of charges

• Developed curriculum, course materials and implemented program for the Medical Assistant and

Sports Medicine Programs at Southwestern Medical Academy, Long Medical Institute and Apollo

College

LORRIE M. MILLS

Tempe, AZ 85281 C: 480-***-**** **********@*****.***

• Experienced instructor for Medical Assistant and Sports Medicine curriculum and medical

vocabulary

• Used variety of teaching techniques to encourage student critical thinking and discussion in patient

care

• Received high remarks for the creativity of classroom lesson plans and instructional techniques

from students, and faculty

• Established, designed and implemented research program for large urology office

• Patient care and surgical procedure experience in Internal Medicine, Family Practice, Urology,

Pediatrics, Rheumatology, Dermatology, Geriatrics, and Sports Medicine

• Exhibited expert knowledge of policies, procedures, ethical standards and laws regarding the

delivery of medical care

• Ensured compliance with medical/legal requirements, JCAHO standards and state regulations

• Prepared for State Health department and JCAHO reviews, ensuring required policies and

procedures were in place and executed in all 14 Scottsdale Healthcare Family Practice Clinics

• Demonstrated knowledge of HIPAA privacy and security regulations by appropriately handling

patient information and maintaining confidentiality of patients, families and colleagues personal

and sensitive information

• Pursued continuing education and training programs to continue professional development

• Created presentation materials for investigator meetings, internal training, customer relations and

management purposes

• Supervised project production efforts to ensure projects completed according to company standards,

on time and within budget constraints

Education and Training

Bachelors of Science in Business Management 2008

University of Phoenix Phoenix, AZ

Emphasis on Project Management

3.8 GPA

Medical Assistance 1985

Southwestern Medical Academy Phoenix, AZ

4.0 GPA

Arizona Life Insurance License 2013

Phoenix, AZ

Professional Computer and Software

• Documentum (DCM) • Windows, Outlook and Microsoft Office

• SAP Suite Selectica - Contract Management

System

LORRIE M. MILLS

Tempe, AZ 85281 C: 480-***-**** **********@*****.***

• TrialWorks (Clinical Trial Management • Publisher and Adobe Photoshop

System)

Affiliations

Society of Clinical Research Associates (SoCRA) since 2006, Cambridge Who's Who, Recipient of

“Who’s Who 2008 Professional of the Year Representing the Clinical Research, Project Management

& Marketing Industry” in 2008, Drug Information Association (DIA), Association of Clinical

Research Professionals (ACRP)

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