Project Manager Registered Nurse

CLINICAL RESEARCH ASSOCIATE

Amy Ackman RN,BSN

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

Carnegie, PA 15016

(H) 412-***-****

(C ) 412-***-****

(W) 412-***-****

EDUCATION

BSN- 2000

Waynesburg College, Pittsburgh, PA

RN- 1987

St. Francis School of Nursing, Pittsburgh, PA

THERAPEUTIC EXPERIENCE

Oncology- all solid tumors

Infections Disease

Diabetes

ADD, ADHD

Hypertension

Vaccines

Women's Health

Dermatology

Osteoarthritis, Rheumatoid arthritis

Liver and Kidney transplant

PROFESSIONAL EXPERIENCE

Bayer Pharmaceuticals- Clinical Site Manager/CRA II, Regionally based

November 2010-Present

. Clinical research on site monitoring of numerous studies and sites.

. Experience conducting site selection, site initiation, interim

monitoring and close out monitoring visits.

. Perform total site management from site selection through close out

visit.

. Perform by patient data cleaning on an ongoing basis, adhering to

strict timelines.

. Working knowledge of ICH GCP, FDA regulations and Bayer SOP's.

. Develop regional territory by evaluating and recruiting investigators

for new clinical studies.

. Provide continuous education with the staff regarding source

documents, protocol adherence, GCP's CRF completion, SAE reporting

and Investigator responsibilities.

. Verify protocol and regulatory compliance at the investigator site.

. Develop collaborative relationships with the investigator site and

sponsor representatives.

. Write thorough visit reports and CAPA's within the required time

frame to describe all findings and actions at the investigator site

during the visits. Ensure all outstanding issues and queries are

resolved in a timely manner.

. Provide continuous support for the site regarding protocol concerns,

recruitment issues, EDC support and deadline support.

. CRA mentor for oncology studies.

Clinforce-Consultant Clinical Site Manager/CRA, Regionally based

Bayer HealthCare Pharamceuticals, October 2009-November 2010

. Clinical research on site monitoring of numerous studies and sites.

. Experience conducting site selection, site initiation, interim

monitoring and close out monitoring visits.

. Perform total site management from site selection through close out

visit.

. Perform by patient data cleaning on an ongoing basis, adhering to

strict timelines.

. Working knowledge of ICH GCP, FDA regulations and Bayer SOP's.

. Develop regional territory by evaluating and recruiting investigators

for new clinical studies.

. Provide continuous education with the staff regarding source

documents, protocol adherence, GCP's CRF completion, SAE reporting

and Investigator responsibilities.

. Verify protocol and regulatory compliance at the investigator site.

. Develop collaborative relationships with the investigator site and

sponsor representatives.

. Write thorough visit reports and CAPA's within the required time

frame to describe all findings and actions at the investigator site

during the visits. Ensure all outstanding issues and queries are

resolved in a timely manner.

. Provide continuous support for the site regarding protocol concerns,

recruitment issues, EDC support and deadline support.

. CRA mentor for oncology studies.

Kforce Functional Service Provider, Pfizer, Clinical Site Manager/CRA

II, Regionally based January 2007- October 2009

. Clinical research on site monitoring of numerous studies and sites.

. Experience conducting site selection, site initiation, interim

monitoring and close out monitoring visits.

. Perform total site management from site selection through close out

visit.

. Perform by patient data cleaning on an ongoing basis, adhering to

strict timelines.

. Working knowledge of ICH GCP, FDA regulations and Bayer SOP's.

. Develop regional territory by evaluating and recruiting investigators

for new clinical studies.

. Provide continuous education with the staff regarding source

documents, protocol adherence, GCP's CRF completion, SAE reporting

and Investigator responsibilities.

. Verify protocol and regulatory compliance at the investigator site.

. Develop collaborative relationships with the investigator site and

sponsor representatives.

. Write thorough visit reports within the required time frame to

describe all findings and actions at the investigator site during the

visits. Ensure all outstanding issues and queries are resolved in a

timely manner.

. Provide continuous support for the site regarding protocol concerns,

recruitment issues, EDC support and deadline support.

Health Decisions, Regionally based CRA July 2006-January 2007

. Clinical research on site monitoring of numerous studies and sites.

. Experience conducting site selection, site initiation, interim

monitoring and close out monitoring visits.

. Perform all Lead CRA duties for oncology vaccine trial to include

reference for other CRA's and sites, provide weekly updates to the

study team, and assist with recruiting and education sites on the

protocol.

. Perform by patient data cleaning on an ongoing basis, adhering to

strict timelines.

. Working knowledge of ICH GCP, FDA regulations and Bayer SOP's.

. Develop regional territory by evaluating and recruiting investigators

for new clinical studies.

. Provide continuous education with the staff regarding source

documents, protocol adherence, GCP's CRF completion, SAE reporting

and Investigator responsibilities.

. Verify protocol and regulatory compliance at the investigator site.

. Develop collaborative relationships with the investigator site and

sponsor representatives.

. Write thorough visit reports within the required time frame to

describe all findings and actions at the investigator site during the

visits. Ensure all outstanding issues and queries are resolved in a

timely manner.

. Provide continuous support for the site regarding protocol concerns,

recruitment issues, EDC support and deadline support.

PPD, Regionally based CRA III September 2005-July 2006

. Clinical research on site monitoring of numerous studies and sites.

. Experience conducting site selection, site initiation, interim

monitoring and close out monitoring visits.

. Perform by patient data cleaning on an ongoing basis, adhering to

strict timelines.

. Working knowledge of ICH GCP, FDA regulations and Bayer SOP's.

. Develop regional territory by evaluating and recruiting investigators

for new clinical studies.

. Provide continuous education with the staff regarding source

documents, protocol adherence, GCP's CRF completion, SAE reporting

and Investigator responsibilities.

. Verify protocol and regulatory compliance at the investigator site.

. Develop collaborative relationships with the investigator site and

sponsor representatives.

. Write thorough visit reports within the required time frame to

describe all findings and actions at the investigator site during the

visits. Ensure all outstanding issues and queries are resolved in a

timely manner.

. Provide continuous support for the site regarding protocol concerns,

recruitment issues, EDC support and deadline support.

UPMC Hillman Cancer Center, Study Coordinator

August 2000-September 2005

. Perform all aspects of clinical trial coordination. This includes

recruitment, assess eligibility criteria, conduct and assist with

the informed consent process, perform all protocol required

tests/procedures, verify all study drug was administered according

to protocol and collect and report adverse events that occur with a

subject.

. Perform all aspects of coordination in accordance with the GCP's

and Federal Regulations.

. Assist CRA with monitoring visits to correct data errors in the

CRF, clarify discrepancies with the CRA, and resolve follow up

issues and queries in a timely manner.

University of Pittsburgh Institutional Review Board, Research Review

Coordinator May 2003- September 2005

. Perform comprehensive review of all clinical trials conducted at the

University of Pittsburgh to ensure subject safety, compliance with

local and federal regulations and compliance with GCP's

. Assess all serious adverse events and protocol deviations to assess

for safety and trends.

. Assist with continuous educations for the research community and board

members.

. Provide clinical expertise for oncology trials for the board members

and peer members at the IRB.

Primary Physicians Research, Study Coordinator/Project Manager

December 1996- August 2000

. Project Manager for all study coordinators at satellite research sites

to assist with job performance, teaching, inservices, and all study

related procedures including regulatory compliance.

. Perform all aspects of clinical trial coordination. This includes

recruitment, assess eligibility criteria, conduct and assist with the

informed consent process, perform all protocol required

tests/procedures, verify all study drug was administered according to

protocol and collect and report adverse events that occur with a

subject.

. Perform all aspects of coordination in accordance with the GCP's and

Federal Regulations.

. Assist CRA with monitoring visits to correct data errors in the CRF,

clarify discrepancies with the CRA, and resolve follow up issues and

queries in a timely manner.

Magee Women's Hospital, Registered Nurse/Charge Nurse NICU

May 1987-December 1996

. Perform all aspects of care for patients and critically ill infants

in a 70 bed Level III NICU.

. Charge nurse and education for night shift staff.

Certification

Certified Clinical Research Coordinator, Association of Clinical Research

Professionals, April 2000

Professional Development

. Advanced Clinical Monitoring Course, July 2011

. Clinical Research Associate Foundation Training Course, PPD 2005

. Above and Beyond Award Kforce for Monitoring 2008

. Above and Beyond Award Bayer 2009, 2011

. Cheers for Peers Award Kforce for Territory Development 2009

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