FRANCES GEORGE

Phone: 520-***-****

Email: adnmig@r.postjobfree.com

SUMMARY

Clinical research professional with over ten years experience at Site and Contract Research Organization (CRO) levels as a Clinical Research Coordinator and Clinical Research Associate. Management and leadership experience as an independent contractor and within team environments.

The demonstrated ability to direct clinical trials from startup to close out. Facilitated clinical trials in many therapeutic areas to include, pulmonary/respiratory, allergy, gastroenterology, retina, ophthalmology, endocrinology, rheumatology, autoimmune, infectious disease, sexual dysfunction, fertility, gynecology and women’s health. Skilled in documentation both written and electronic. Proficient in computer programs and data entry programs specific to clinical trial protocols and general computing technologies. Well versed in all Good Clinical Practices (GCP) and ICH guidelines of clinical trial operations. Proven ability to work in unison with superiors, peers, staff and customers / patients to achieve objectives, meet strict guidelines, and maintain protocols per standard operating procedures

(SOP) at all times.

PROFESSIONAL EXPERIENCE:

Surgery/Covid 19

June 2019 - Present

I took a medical leave of absence to have a surgery and after a full recovery Covid 19 shut down my ability to return to work.

Arizona Arthritis and Rheumatology Research, PLLC

Clinical Research Coordinator - Focus Clinical Research Group February2017 - May 2019 (2 year 3 month contract Tucson, Arizona) October 2016 - January 2017 (3 month contract Phoenix, Arizona) Contractor position covering sites in Phoenix, Arizona and Tucson, Arizona. Responsible for site start-up in a new office in Tucson, Arizona which included training physicians, site staff, and infusion nurses. Conducted research studies from site start-up to close-out visits. Set up contracts with ancillary facilities needed to conduct trials. Interpret Spanish/English advertising, patient information, and physicians orders.

Major Motor Vehicle Accident Recovery and Surgeries March 2011 - October 2016

I had to take a medical leave of absence to focus on my rehab due to injuries from a motor vehicle accident. After more than five years of surgeries and rehab I successfully overcame several back fractures and made a full recovery.

Obstetrix/Pediatrix

Clinical Research Associate Coordinator

November 2010 - April 2011

Conducted clinical research with Pediatrix Medical Group in maternal-fetal, newborn and pediatric medicine within 33 states and Puerto Rico. Managed all aspects of an in house study to include regulatory, source verification, data entry, case report form completion, and weekly reports. Monitoring clinical trials in compliance with FDA regulations as well as adhering to Good Clinical Practice guidelines. Attend investigator meetings as well as train clinical research coordinators. In house position that required the ability to take over any position that needed to be filled in an emergency. Attend and speak at investigator meetings throughout the United States in order to train for upcoming trials.

Focus Clinical Research Group, LLC

Contract Clinical Research Associate-Home-Based

November 2009 – November 2010

Start up sites, regulatory, source verification, train, coordinate, monitor, and quality control. Responsible for monitoring site assignments for clinical pharmacokinetic trials. Assures adherence to Good Clinical Practice (GCP), investigator integrity, and compliance with protocols. Provides monitoring and reporting of clinical pharmacokinetic trials. Quintiles Global Access to Patients

Clinical Research Coordinator- Home -Based

June 2008 - October 2009

Promoted Access to Patients (ATP) program in the Tucson area to expand physician participation in clinical research trials. Recruited and presented ATP program to local physicians through regular contact and follow up which resulted in the startup of two study sites in the Tucson area. Managed two sites in the Tucson area and examined existing research facilities capabilities and procedures to determine site quality for ongoing / increased participation in ATP program. Lead project manager for two influenza vaccine trials of 340+ subjects in the Tucson, Arizona clinic. Ensured solid team effort resulting in a successful sponsor audit and data analysis. I determined staff requirements, completed subject visits, electronic data entry and query resolution. Facilitated continual progress along with problem resolution meeting all sponsors deadlines. Implemented source verification to ensure quality work throughout trials. Oversaw the quality of an erectile dysfunction study at a partner site. Available for Phoenix area partner sites as backup as well as backup for any colleague throughout the west coast in order to meet sponsor deadlines. Received 10 "Work Worth Doing" recognition awards from management and colleagues for dedication, attention to detail, integrity, quality, teamwork, organization and contributions to the company.

Catalina Pointe Clinical Research, Inc.

Senior Clinical Research Coordinator

March 2006-June 2008

Lead Senior Site Coordinator responsible for the management of all aspects of the clinical research trial process in the therapeutic area of rheumatology and autoimmune disease; to include supervision of four Clinical Research Coordinators. Managed day-to-day operations of clinical research sites and evaluated subordinate job performance, to include training, overall work performance and disciplinary issues. Duties included investigational study selection, feasibility assessment, budget preparation/negotiation, regulatory document preparation and project negotiation. Development and implementation of standard operating procedures. Conduct staff in-services prior to implementation of new research trials. Tracked progress of projects and identified appropriate actions to achieve target enrollment. Retina Centers P.C.

Clinical Research Coordinator June 2003-March 2006 Responsible for recruiting and pre-screening patients for current and upcoming studies. Prepare and submit all regulatory documents. Negotiate budgets and contracts as well as bill procedures. Conduct telephone interviews and telephone safety follow-up phone calls. Consent patients and address any questions or concerns. Coordinate all study visits to occur according to protocol. Set-up and assist physicians in intravitreal injections. Administer Visudyne for Photodynamic Therapy. Intravenous infusions of study medication. Perform visual field exams, ocular pressure checks, phlebotomy, electrocardiograms, and vitals. Complete case report forms and address queries. Attend investigator meetings and set -up for new studies. Ensure that all technical staff have completed procedures so that protocol is followed. Arizona Clinical Studies, Tucson, Arizona

Clinical Research Coordinator / April 2002-April 2003 Responsible for coordinating clinical trials in compliance with FDA regulations as well as adhering to Good Clinical Practice guidelines. Attend investigator meetings; consent subjects, conduct pre-screens, conduct study visits and ensure the subject is in compliance with protocol. Assist investigators with physicals as well as perform phlebotomy, electrocardiograms, pulmonary function tests and vitals. Complete source documents, resolve queries, assist monitors with initiation visits as well as close out visits. EDUCATION:

2009-2011 University of Phoenix, Tucson, Arizona

Bachelor of Science in Healthcare Administration Coursework 1995-1997 Apollo College, Tucson, Arizona

Associate of Occupational Studies Degree

Medical Laboratory Technology

1997 Apollo College, Tucson, Arizona

Electrocardiograph Technician Course

1991 -1992 Apollo College, Tucson, Arizona

Medical Assistant Program

CONTINUING EDUCATION:

Sep. 2006 Pima Community College, Tucson, Arizona

Infusion Therapy Certificate

Dec. 2005 Association of Clinical Research Professionals, Dallas, Texas Business Development Budgeting and Contract Management Mar. 2005 Association of Clinical Research Professionals, Las Vegas, NV Intermediate Clinical Research Course

Oct. 2003 Association of Clinical Research Professionals, New Orleans Fundamentals of Clinical Research Trials

Nov.1995 CACMLF, Denver, Colorado

Phlebotomy Certificate

Special Skills:

Bilingual: Fluent in Spanish, written and speaking Computer Literate

Excellent interpersonal skills

Excellent organizational skills

Contact this candidate