DENISE CRONIN

Philadelphia, Pennsylvania Area

*** ******** *****

Warrington, PA 18976

Cell Number: 215-***-****

acgga7@r.postjobfree.com

SUMMARY:

. 8 years Clinical Research experience including:

o 7 years Regional Clinical Research experience

o 1 year Nurse Coordinating experience

. Current workload: 6 studies, 75 sites, Cardiac devices, leads and

Stents

. Largest workload: 7 studies, 100+ sites, Cardiac devices, leads,

stents, heart failure and home monitoring

. Drivable locations: Philadelphia metro area, Harrisburg, Altoona,

Lower DE, Upper MD, Southern NJ.

. Train to NYC, CT and Washington DC

. Located 45 minutes from the Philadelphia International Airport with

direct flights to all major cities.

THERAPEUTIC EXPERIENCE:

Regional Clinical Research Associate:

. Cardiac Device

o Pacemakers-IDE, Post Approval, After Market

o Defibrillators-IDE

o CRT Device-IDE

o Femoral Iliac Stent-IDE

o Coronary Stents-IDE

o Pacemaker Lead-IDE

o Home monitoring device for atrial fibrillation (large drug

component)-After Market

o ICD Ventricular Lead-IDE

o LV Lead for heart failure-Post Approval

Nurse Coordinator:

. Spinal Cord Injury

o Respiratory Measurement

o Muscle Testing

PROFESSIONAL EXPERIENCE

BIOTRONIK INC., US Headquarters, Lake Oswego, OR February 1999 to June

2014

Leading manufacturer of pacemakers, defibrillators and CRT devices

worldwide

Senior Regional Clinical Research Associate (RCRA) (February 2007 to

Present)

. Responsible for coordinating and performing all aspects of clinical

monitoring in compliance with FDA regulations, ICH/GCP guidelines and

company SOPs

. Currently worked with six protocols including IDE, post-market, and

FDA post approval protocols

. Conduct site visits to determine protocol and regulatory compliance

. Ensure integrity of study data is accurate and complete to allow

proper evaluation of device performance

. Conduct Basic Research training to site coordinators, and train new

regional monitors

. Serve as a presenter at Biotronik CRC Workshops and Investigator

Meetings

. Must be able to diffuse and resolve issues at investigative site level

and sustain a strong communication link with project teams

Senior Field Clinical Specialist / Regional Trainer (February 1999 to

February 2007)

. Responsible for being in attendance for pacemaker and ICD implants,

bringing product to the implant, running the analyzer and doing

paperwork involved, must also interact with the physician and hospital

staff, answering any questions that may come up about the product line

and /or the company

. Possess clinical studies in my territory, includes training of site

coordinators and physicians on the Protocols, device interrogation and

programming and the collection of device data for IDE and post-market

studies

. Provided patient follow-up in clinic and hospital setting, includes

troubleshooting as needed

. In-service of staff in the use of the programmer and general workings

of the devices

. Kept physicians and staff updated on new technology

. Served as a Regional Trainer for new and current reps (2003 to 2005)

. Provided support to the company reps in the field

. Planned and organized the Regional Nurses Meetings for the Northeast

Region of USA - September 2003 and January 2004

SULZER INTERMEDICS, Angleton, TX April 1998 to February 1999

Device manufacturer of pacemakers and defibrillators.

Field Clinical Specialist

. Responsible for being in attendance for all pacemaker implants

. Provided patient follow-up in the clinical and hospital setting

. Tachycardia certification achieved.

. In-service of staff in the use of programmer and general workings of

the device

ST.JUDE MEDICAL, St. Paul, MN September 1997 to April 1998

Device manufacturer division for pacemakers and defibrillators.

Field Clinical Specialist

. Responsible for being in attendance for pacemaker implants in the

region

. Provided patient follow-up in clinic and hospital setting. Includes

troubleshooting as needed

. Provided training for implantable defibrillators

TELECTRONICS PACING SYSTEMS, Denver CO

April 1995 to September 1997

Cronin Medical was a large representative group for Telectronic's pacemaker

and vascular product lines.

Field Clinical Specialist for Cronin Medical, Inc. (July 1993 to April

1995)

Sales Representative for Cronin Medical, Inc. (April 1995 to September

1997)

. Covered 20 accounts in territory SE Pennsylvania and Southern New

Jersey

. Sales included: pacemakers, pacemaker leads

. National and Regional Rep Group FY 1994

. Also carried the Bio-Vascular product line

GRADUATE HOSPITAL, Philadelphia, PA February 1988 to April 1995

Clinical Perfusionist

. Adult heart perfusion, IABP, arterial and venous blood gas monitoring

. Cell saving for the heart team as well as general OR

EPISCOPAL HOSPITAL, Philadelphia, PA 1986 to January 1988

Clinical Perfusionist

. Adult heart perfusion, IABP, Arterial and venous blood gas monitoring,

Cell saving

MULTIPLE NURSING POSITIONS. Philadelphia, Pa September 1975 to

January 1986

Staff Nurse

. Full time positions included: medical-surgical nursing, ICU, CCU,

PACU, Spinal Cord Injury rehabilitation (both nursing and

administrative)

. Part time positions included: Community Health nursing with the

Allegheny Health System working with the mentally challenged and brain-

injured

. One year of Research with the Spinal Cord Injury Program at Thomas

Jefferson University Hospital. Research included Consenting patients

and collection of data for the Research Department

EDUCATION:

St Mary Hospital School of Practical Nursing, Philadelphia, PA

Diploma, PA License # PN 061345L - Current

Mississippi School of Perfusion Technology, Jackson, MS

Board Eligible, Diploma

Research Courses/Workshops:

CITI Training- GCP Basic Course

2012

SoCRA and FDA sponsored Course on FDA Clinical Trial Requirements,

Regulations Compliance and GCP, Minneapolis, MN

Certificate 2009

Barnett Educational Serviced Course on "Writing for Research",

Philadelphia, PA 2008

Certificate

CfPIE Course on "How to Monitor Clinical Trials for GCP Compliance,

Philadelphia, PA 2007

Certificate

Barnett Educational Services Course on "Comprehensive Monitoring for

Medical Devices, Philadelphia, PA 2007

Certificate

PROFESSIONAL MEMBERSHIPS:

Membership to Society of Clinical Research Associates (SoCRA) ID# 28258

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