Medical Clinical Research

********@***.***. 602-***-****

Amie Walsh

Experience

January 2011-Presen

Medlock Consulting, LLC. Owner/President

Ten years of experience in medical research and clinical development

Conducted both medical device and drug research studies nationwide

Strong management skills, team development skills and organizational

skills

Experience in corporate medical research and health-care medical

research

Clinical Monitoring

Clinical Research

Project Management

Clinical Research Coordinator Training & Education

EDC and EMR

January 2011-Present Bard Peripheral Vascular, Inc.

Phoenix, Arizona

Regional Senior Clinical Research Associate Consultant

Regional contract CRA position with Bard Peripheral Vascular, Inc.

Monitor the investigators and study staff for adherence to the protocol

and GCP guidelines

Conduct various types of monitoring visits including pre-study

selection, site initiation, interim, and close-out visits

Remote monitoring with EDC system and site correspondence

Clean, precise, timely monitoring report writing

Develop CRFs and other study templates

Experienced in Vascular Device Studies

Ensure overall quality of clinical studies by monitoring and managing

clinical data generated by sites

September 2010-February-2011 UnitedHealth Group- i3 Pharma Global

Resourcing Division

Home-Based Contractor

Performed eTMF review and QC activities using the Sponsors systems and

tools

Identified discrepancies and missing information related to site

specific documents

Prepared project for an organized and smooth FDA Audit

Executed assigned projects to meet strict timelines

Reviewed all documentation in Trial Master Files including Essential

Documents and CRFs

Conducted QA on site specific regulatory documentation and protocol

specific documents

Remotely Monitored Global Clinical Research Documentation for a large

Pharmaceutical Company

April 2006-May 2010 Arizona Heart Institute

Phoenix, Arizona

Clinic Supervisor

Successfully managed head cardiothoracic/vascular surgeon's clinic

Supervised Medical Assistants and other back office staff. Established

and maintained a collaborative working relationship with 13 providers

and front office staff to ensure smooth patient flow and the provision

of high quality services

Demonstrated the ability to perform multiple administrative functions

simultaneously in an accurate, organized, and efficient manner. Ability

to multitask and thrive in a fast-paced, constantly changing environment

Carried out all responsibilities in an honest, ethical and professional

manner and demonstrated good judgment

Built a strong successful medical staff through good management skill

Directed weekly staff meetings and monthly general staff meetings

Member of the executive revenue-cycle team

Identified strong candidates for research protocols

Prepared curriculums and facilitated Medical Assistant training modules

Supervised medical supply ordering

Provided information for reports as needed

Implemented quality improvement projects

April 2005-April 2006 Arizona Heart Institute

Phoenix, Arizona

Lead Clinical Research Coordinator

Developed and directed Interventional Research projects to ensure

patient safety and compliance to protocol using GCP, CFR, and ICH

guidelines

Screened and enrolled patients for approved studies; administered

informed consent forms

Taught patients about disease process and protocol treatment schedule

Multiple device experience. Endoluminal grafts, carotid stents, PVD

stents, angioplasty devices

Completed documents required by research protocol and clinical programs

Maintained contact with sponsors, maintained associated logs, reports,

and device accountability

Demonstrated proficiency in clinical skills required by study protocols

Assisted Investigators in OR/Cath lab with study procedure

Skilled in maintaining and supporting regulatory compliance within

clinical studies

April 2004-April 2005 Alliance Property Management Phoenix,

Arizona

Assistant Manager/Top Sales Rep

Managed a 224 unit luxury apartment complex. Responsible for selling a

life-style and community in a highly competitive industry. Increased

net occupancy revenue and maintained a budget.

Top Sales Rep company wide

Responsible for accounting, payroll, month-end closing reports and owner

reports

Completed market surveys, marketing ideas and advertisements

Consistently scored high on monthly mystery shops sent from corporate

office

2002-2004 Pharmaceutical Product Development (PPD) Phoenix,

Arizona

Regional Clinical Research Associate

Conducted Phase II, 1200 patient central nervous system-Multiple

Sclerosis Study. Oversaw 15 Neurological research centers nationwide.

Trained medical research staff on medical protocols and study design.

Lectured physicians about physiological study drug actions. Monitored

drug inventory, subject safety, documentation, adverse events,

biological samples, protocol violations and study conduct. Enforced

Good Clinical Practice guidelines, FDA regulations and protocol

adherence.

Established, maintained and retained strong relationships with

physicians and study staff

Quickly resolved and improved study related discrepancies

Analyzed subject recruitment and met critical study related timelines

2000-2002 Alteon, Inc. Ramsey,

New Jersey

Clinical Research Associate

Interviewed and selected over 100 qualified research centers to

participate in cardiovascular and diabetes studies; Phase I, II, and

III. Managed the clinical overall study and medical staff. Performed

pre-study, initiation, interim and closeout visits. Audited regulatory

files according to Good Clinical Practice guidelines and FDA

regulations. Implemented an electronic data capture system to record

medical data for final study analysis.

Acted as liaison between the clinical research department and

PR/corporate communications

Established professional relations with Board Certified Physicians and

the entire medical study staff

Education

December 1999 - Tempe, AZ

Bachelor of Arizona State University

Science/Biology

PROFILE

Excellent verbal and written communication

Strong organizational & management skills

Knowledge of medical terminology

Well-versed in research methodology

Motivated and results-oriented

TRAINING AND CERTIFICATIONS

Clinical Research Training (NIH)

CPR certified

HIPAA Training for Researchers: HIPAA and Clinical Trials

Human Participants Protection Education for Research Teams

HIPAA Training for Clinical Staff

Clinical Research Associate Foundation Program - June 2002

Monitoring Clinical Trials for Good Clinical Practice Compliance - March

2001

SoCRA

SKILLS

Microsoft Office, Excel, PowerPoint, Access, Outlook, Clinic

Automations, Epic, Centricity, eTMF, eCRF, EDMS Systems, InForm, and

TrailWorks.

ICH, GCP, GLP, GMP, ISO Requirements, HIPAA and other FDA Regulatory

Compliance Guidelines

Centricity Physician Office Practice Management.

Contact this candidate