SUMMARY

High Tech Infusion Registered Nurse (RN) with more than 20 years in nursing and healthcare. Patient educator/advocate. Extensive knowledge in Specialty Infusions IVIG, SCIG and many other biologics for patients with rare disease (orphan drugs). Organized and detail oriented able to work independently and problem solve in the healthcare field.

EXPERIENCE

Allergy Associates of the Palm Beaches, P.A. – North Palm Beach, FL August 2021-August 2022

Mark R. Stein, M.D., Alan P. Koterba, M.D., Elena E. Perez, M.D.

Department Manager-Infusion Services

Managed high volume infusion suite for three physicians specializing in treating patients with immune deficiencies, neurologic and auto-immune conditions. Monitor patients during infusion for adverse events, SCIG patient training and education on primary immune deficiencies, extensively interact with specialty pharmacies, prior authorization, patient advocacy, billing Medicare claims, prepayment reviews, redeterminations and audits. Train nursing staff, worked closely with physicians on clinical trials for new immunoglobulin products.

Accredo Health Group A Cigna Company – Bloomfield, CT March 2018-July 2021

Admissions/ SOC, RN/physician orders, chart audits and discharges. Provide in home infusions, education and advocacy for patients with rare diseases providing care for patients with immune deficiencies, neurologic, auto immune, bleeding disorders, rheumatology, Gauchers Disease, HIV, HAE, Alpha-1 antitrypsin deficiency and a multitude of other rare disease conditions. Monitor patients during infusion for adverse events, patient training on disease process, adverse events and self administration if indicated.

Private Nursing Care, Inc -Vero Beach, FL May 2013-2021

High Tech Infusion Nurse

Provide direct in home patient care infusing IVIG, SCIG and vitamin replacement infusions. Patient assessment and safety.

Allergy Associates of the Palm Beaches, P.A. – North Palm Beach, FL May 2013-March2018

Mark R. Stein, M.D., Alan P. Koterba, M.D., Elena E. Perez, M.D.

Department Manager-Infusion Services

Managed high volume infusion suite for three physicians specializing in treating patients with immune deficiencies, neurologic and auto-immune conditions. Monitor patients during infusion for adverse events, SCIG patient training and education on primary immune deficiencies, extensively interact with specialty pharmacies, prior authorization, patient advocacy, billing Medicare claims, prepayment reviews, redeterminations and audits. Train nursing staff, worked closely with physicians on clinical trials for new immunoglobulin products.

SKILLS

Highly experienced/certified in peripheral IV’s, PICC’s, midlines and ports (IV certified)

Strong knowledge in IV therapy and advances in IV therapy

Reporting and correspondence

IV and SQ drug administration

Patient/ training IV, SQ, drug therapy management and education

Home infusion specialist

Documentation and record-keeping with adequate detail, experienced in several EMR programs

BLS

Patient care, vital signs and assessment Highly knowledgeable rare disease and chronic disease process

Able to work independently

Extensive experience in IVIG/ SCIG

Biologics and biosimilars

Excellent judgment decision making abilities and problem-solving skills

RESEARCH EXPERIENCE

Allergy Associates of the Palm Beaches, P.A. – North Palm Beach, FL

Mark R. Stein, M.D., Alan P. Koterba, M.D., Elena E. Perez, M.D.

An open-label, multicenter study to evaluate the Pharmacokinetics, efficacy and safety of RI-002 (IGIV) in subjects with Primary Immunodeficiency Disease (PIID). 2013.

• A clinical study of Immune Globulin subcutaneous (Human), 20% solution (IGSC 20%) for the evaluation of efficacy, safety, tolerability and Pharmacokinetics and subjects with Primary Immunodeficiency Diseases (PIID). 2013.

• A phase III, multicenter, open label, randomized, two-period crossover, bio-equivalent study to evaluate the Pharmacokinetics and safety and tolerability of Gammaplex 10 and Gammaplex 5% in Primary Immunodeficiency Diseases (PIID). 2014.

• A phase III, multicenter, open label study to evaluate the Pharmacokinetics and safety of Subgam VF in Primary Immunodeficiency Disease (PIID). 2015.

• Non-interventional 2-armed Study to Evaluate the Safety of Octagam Immune Globulin Intravenous (Human) 5% Liquid Preparation, with a Special Emphasis on Monitoring, Analysis and Reporting of Thromboembolic Events (TEEs). 2015.

• A retrospective record review of Primary Immunology patients who received at least one HyQvia infusion. The Consortium of Independent Immunology Clinics Research Committee (CIIC). 2016.

• A phase III, multinational, multicenter, open label study of the safety, tolerability, efficacy and Pharmacokinetics of ProMedic Bio Therapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children with Primary Immunodeficiency. 2016.

• An open label, multicenter study to evaluate the safety in Pharmacokinetics of IGSC 20 administered for 6 months in subjects with Primary Immunodeficiency. 2016.

EDUCATION

Registered Nurse

Broward State College - Coconut Creek, FL

Florida Atlantic University – Boca Raton, FL

PUBLICATIONS

• new liquid 10% intravenous immunoglobulin (IVIG) administered with 15-minute titration periods allows shorter infusion durations and tolerability similar to 5% formulation.

M. Stein MD, K. Farnan, CCRC, D. Eufrasio, CCRC, B. Boyd, RN, M. Norton, PhD-Bio Products Laboratory, Ltd

MEMBERSMHIPS/CERTIFICATIONS/CME

• IGNS – Immunoglobulin National Society

• INS – Infusion Nurses Society

• NSO – Nurses Service Organization

• IV Certified / Peripheral and Central Lines

• BLS – Basic Life Support

• Collaborative Institutional Training Initiative Course in Human Subjects Research

• National Institute of Health (Protecting Human Research Participants)

Contact this candidate