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Data Entry Clinical Trials

Location:
Satellite Beach, FL
Posted:
April 23, 2025

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Resume:

Patricia Tschanz BSHS, MS, RN ( retired )

****************@*****.***

484-***-****

Phoenixville Hospital: Phoenixville, PA

Case Manager/Utilization Review

. Review medical charts for medical necessity

. Enter data into Interqual program, for insurance approval

EHR: Kenneth Square, PA

Remote: Clinical Case Auditing

March 2012 to 2015

. Review physician statements for accuracy of diagnosis, spelling, terminology and

length of

stay as well as type of stay approved.

. Review case in its entirety for accuracy in dates, physician and payor information and

all

coding information.

. Prepare a narrative summarizing the case and supporting both the medical record and

(previously verified) physician statement.

EXPERIENCE:

Bayer: Montville, NJ

Contract Sr. Drug Safety Specialist-Pharmacovigilence

Oct-2010 to Oct-2011

• Case triage of 7, 15 & 30 day reports according to government mandated

reportability timelines and PVA agreements

• Data entry of clinical trials phases II/III and spontaneous/ solicited post marked

cases.

• Narrative writing for all cases.

• CIOMs creation according to company conventions and PVA agreements

• Source documentation verification and evaluation of non-SUSAR cases

• Data Reconciliation of Clinical Trials

Cephalon: Frazer, PA

Contract Sr. Drug Safety Specialist-Pharmacovigilence

Sep-2009 to Sep-2010

• Case triage of 7, 15 & 30 day reports according to government mandated

reportability timelines and PVA agreements

• Data entry of clinical trials phases II/III, literature and spontaneous/solicited post

marketed cases.

• Narrative writing for all cases

• CIOMs creation according to company conventions and PVA agreements

• Source documentation verification and evaluation of L1 & L2 cases

• Data Reconciliation of Clinical Trials

• Follow up on all unlisted post marketed cases

Bristol-Meyers Squibb: Hopewell, NJ

Contract Drug Safety Specialist-Pharmacovigilence

May-2008 to Sep 2009

• Case triage of 7, 15 & 30 day reports according to government mandated

reportability timelines and PVA agreements

• Data entry of clinical trials phases II/III, literature and spontaneous/solicited post

marketed cases.

• Narrative writing for all cases.

• CIOMs creation according to company conventions and PVA agreements.

ICON: North Wales, PA

Contract Legal Team Drug Safety Associate-Pharmacovigilence

Jun-2006 to May-2008

- Litigation case processing in its entirety, meeting specified timelines.

• Source documentation verification and evaluation.

Abington Memorial Hospital: Abington, PA

Travel Nurse to Permanent Employee

2001-2003

PACU Trauma recovery RN

On call ER Trauma Response

Progressive Nursing: Bala Cynwyd, PA

Contract RN

2001-2006

Moonlighted for local hospitals from 2001-2003 as a flexible and competent team

player-floating to all units (except L&D and Psych)

FT Travel contract to from 2003-2006 for a Shock-Trauma Unit

Anaheim Heart & Research: Tustin, CA

Lead Clinical Research Coordinator

1995 to 2000

- Conducted a multitude of in hospital clinical trials including:

* Swan-Ganz (to evaluate effectiveness of study drug on treating CHF)

* PTCA (to evaluate the instances of re-stenosis after stent treated implantation)

* CABG (to evaluate the effectiveness of study drug on the psycho-neuro

component, when given prior to bypass initiation)

- Provided continual education and guidance to patient’s participating in trials.

- Conducted all post procedural follow ups independently and according to study

protocol.

Santa Ana Hospital and Medical Center: Santa Ana, CA

1987-1989: Critical Care Manager (ER, ICU, Telemetry)

Interviewed and Employed RN’s

Balanced FTE’s for all units

Provided daily assistance and guidance to all customers and staff.

Implemented a quality assurance program and provided education for staff based on

review outcomes.

1990-1992: Evening Nursing Supervisor

- Arranged staffing needs based on each unit’s occupancy level.

- Problem solved patient, staff and other hospital related issues as they arose.

- Provided assistance to all units upon request, including codes and unexpected

emergency procedures.

Pharmacy liaison for all units.

1992-1995: Pre-admission Screening, Utilization Review and Discharge Planning.

Provided assistance to physicians to determine if patient admission met Interqual and

insurance criteria.

Provided daily monitoring of patients status and need for further hospital stay approval.

Communicated daily with TPA’s, insurance companies, physicians, staff, patients and

their families regarding the patient’s anticipated discharge needs.

Shore Memorial Hospital: Somers Point, NJ

New Grad Critical Care (ICU/CCU) RN

1986-1987

EDUCATION:

University of La Verne: La Verne CA

Masters in Healthcare Administration

1997-1999

Chapman University; Orange, CA

Bachelors in Health Sciences

1992-1994

Franklin & Marshall University: Lancaster, PA

Associates in Science

1982-1986

Lancaster General Hospital School of Nursing: Lancaster, PA

RN Diploma

1982-1986

ADDITIONAL INFORMATION:

Past certifications have included, trauma, emergency, critical care, telemetry/medical

surgical and oncology. I also held teaching credentials in the state of CA.

SOFTWARE SYSTEMS COMPETENCY:

RAVE, MedDRA, WHODD, Clintrace, Arisg, Argus and several other Pharma “home

grown” systems, Interqual, Hedis, Windows, Word, Excel and PowerPoint.



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