Registered Nurse Project Manager

Qualifications: Clinical Project Manager

. Experience - 10 years related clinical experience with 5 years in

sustainability, analysis of health care and outcomes date, research

studies implementation, health economics, scientific presentations and

publications, data analysis and trending, 5 years leadership with policy

decision-making and knowledge of product development and

commercialization and direct experience with clinical research site

operations and outcomes research.

. Site based research experience - Robert Johnson Hospital Hamilton

Institutional Review Board Compliance Officer, Novo Nordisk, Johns

Hopkins, Meridian Health Systems, Premier Cardiology Associates and

Johnson and Johnson trials delivery

. Clinical Development Process - Phase 1-IV -studies include thrombolytic,

birth control, insulin pharma, test market OB Tampons and cardiovascular

research

. Information Systems Proficient -Microsoft Office, EDC, IVRS, Clinphone,

and multiple hospital based systems

. Leadership - Direct responsibility for physicians, research and ancillary

staff inclusive of day-to-day management.

. Interpersonal Skills - Strong ability to emerge from difficult situations

positive and noted for energizing staff to accomplish goals

. Program Development/Implementation -Nurse Peer Review, Institutional

Review Board, NJ Atlantic Cardiovascular Patient Outcomes Team Trial

Consortium, Acute Myocardial Infraction Task Force, Atlantic

Cardiovascular Patient's Outcomes Research Trial, Disease Management

Algorithm Application writing, Heart Failure & Diabetes Case Management.

. Publications, Selected - "is it Research or Performance Improvement",

presented at Summer Research Symposium for Robert Wood Johnson University

Hospital, "Door to Balloon Best Practice and Cardiac Catheterization

Laboratory for Critical Care Nurse."

. Research Grant Submissions, Awards and Collaborations, Selected -

Submission - State of NJ DOH Application for Angioplasty Licensure,

Collaboration - State of NJ DHS $250K Cardiovascular Outreach Grant for

"Early Detection and Prevention of Heart Disease", Submission - American

Heart Association National Research Programs Pharmaceutical Roundtable

Grant for "Efficacy of Sustained Release Bupropion (Zyban) to Promote

Smoking Cessation in Angioplasty Patients."

. Travel - ratio of travel to home base desired 50/50%

Education/Certifications

Masters in Health Administration, Seton Hall University, South Orange, New

Jersey

Bachelor of Science, Douglass College, Rutgers, the State University, New

Brunswick, NJ

Minority Nurse Leadership Fellow, Rutgers University, School of Nursing

Registered Nurse Licensure, State of New Jersey

Therapeutic Experience

. Cardiovascular, Endocrinology and Metabolic, Psychiatry, Infectious

Disease, Gastroenterology, Pulmonary and Autoimmune Diseases

Professional Experience

Robert Wood Johnson University Hospital Hamilton, Hamilton, NJ 2006-August

2010

Interim Director/Clinical Research, institutional Review Board Compliance

Officer and Member, Research Coordinator, Registered Nurse, Clinical

Research Coordinator

. Operations -Guided researchers and CROs through the research

application and approval process. Assumed all responsibilities for

federal compliance. Project planning, research delivery oversight

Independently managed, with oversight for all aspects of the execution

and conduct of demonstration and pharmaceutical trials in accordance

with FDA regulations and GCP guidelines.

. Research Venues - Diabetes, oncology, cardiovascular, device and

nursing research

. Personnel- Overall supervision, staff selection, training,

professional development, performance appraisal, performance

improvement plans and problem resolution. Managed 15 staff and 6

physicians

. Site Selection - Very familiar with appropriate venues, site staff and

physician experience required for successful research project

delivery. Designed and set-up state of the art diabetes research

delivery setting.

. Budget - Annual research feasibility study and budget management.

QMed, Inc., Interactive Heart Management Corporation, Eatontown, NJ 2002-

2006

Associate Director Clinical Services. Internal product/service development.

Device, research, disease management contacts private insurers and the

Center for Medicare and Medicaid Services.

. Operations - Inaugurated Heart Failure Disease Management and Research

"Go Live" for this company. Contracts with insurance and government

entities for purchased services. Weekly status reports with

departmental plan, actions and goals. Responsible for meeting

organization's project projections

. Venues - Projects in New Jersey, California, Kentucky, Texas and West

Virginia. Oversight for vendor selection, recruitment and training

and provided final recommendations

. Interacted with sites to monitor completion of assignments, data

management and study reporting activities

. Information Systems - clinical algorithms and managed Ohms Data Center

. Personnel - managed internal and field monitor traveling staff of 50+

data collectors and nurses. Supervised field monitors and assessed

quality of work through review of monitoring reports. Managed 50+

staff

Meridian Health Systems, Jersey Shore Medical Center, Neptune, NJ 1994-2003

Staff Nurse, Nurse Supervisor, Nursing Research Coordinator

. Administered Community Outreach Grant Project DHSS 2003 - Heart

Failure Early Intervention Outreach for 1800 community residents

. Data collection and analysis

. Built internal healthcare delivery environment grossing revenues in

excess of $21 million annually

Premier Cardiology Research/Pharmaceutical and Device Trials - 2000

Phase II - Thrombolytic Pharma Study Research Coordinator

Johnson & Johnson

Contract Manufacturing Manager

. Test Market OB Tampons for Contract Manufacturing

. Birth control pharma research as an extern

Contact this candidate