Administrative Assistant Medical

Anna Najder

adb9cw@r.postjobfree.com 224-***-**** 811 Hibbard Road, Unit C, Wilmette, IL, 60091

OBJECTIVE

Leverage Masters and Medical Degrees in clinical trials for development of new drugs for cancer treatment

EDUCATION

NORTHWESTERN UNIVERSITY Evanston, IL

M.S. Regulatory Compliance Clinical Research Track June 2015

Studied CFR, FDA, NIH regulations, GCPs, IRB, QMS

1. Designed, with a team, protocol for Phase III clinical trials, particular responsibility for research background,

inclusion, exclusion criteria, end points, visits schedule

2. Developed budget and written consent forms

3. Proposed audit for compliance program

4. Capstone Research Project: DePuy Metal on Metal Hip Implant Recall Reviewed and analyzed a 2010 recall to

determine why product/procedure failed. Identified the compliance lapses and how the risk could have been

mitigated. Made recommendations for CAPA to prevent it happening, with this and similar products in the future

POMORSKI UNIWERSYTET MEDYCZNY Szczecin, Western Pomerania, Poland

MD May 1991

Scholarship for academic excellence, Deans List

SKILLS

Knowledge of 21, 45 CFR, ICH-GCPs

Medicine, Clinical Science, Medical Terminology

Clinical trials design, abstracts, protocol development

Regulatory overseeing of phase I/II and III trials

eCRF, Rave, InForm, EPIC, EDC

CITI training, GCP, HAZMAT

FDA regulations for new drug/medical device development

Responsible Conduct of Research, IRB, ICF, Protection of Human Subjects

QMS, CAPA, Risk Management, ISO, SOPs

Apheresis, blood banking

Word, PowerPoint, Office, Outlook

Fluent in Polish, English, limited Russian and German

PROFESSIONAL EXPERIENCE

LOYOLA UNIVERSITY CHICAGO, CARDINAL BERNANDIN CANCER CENTER, CCTO

Clinical Protocol Coordinator/Leukemia 03/2017 Present

IRB submissions of ICF's, Protocol Amendments, Investigational Brochures, Action Letters, MedWatch,

Safety Reports; writing Abstracts; developing ICF;

Responsible for clinical studies concentrated on Leukemia, Lymphoma and BMT

EDC, eCRF (Rave MediData, InForm), answering queries; experience with EPIC in extraction of crucial

data

Start-up and maintenance of existing trials for Pharma and Cooperative Groups,

Internal audits; Protocols, developed patient tracking and regulatory tracking tools,

Overseeing Lab specimen processing, storage and shipment; created SOP for Lab specimen handling,

equipment maintenance; developed various CAPA for lab collection improvements

Training new hires in Lab processing and regulatory

LIFESOURCE, CHICAGOLANDS BLOOD CENTER (PARENT COMPANY ITXM) Rosemont, IL

Blood Donor Specialist 10/2010 03/2017

Understand and performed apheresis procedures: plateletpheresis, plasmapheresis, erythropheresis on Trima,

Amicus, Alyx, and Auto-C machines

Assessed, screened and consent donors and patients for blood donation and therapeutic phlebotomy

Performed second review of apheresis charts

Collaborated in pilot project for paperless procedure on Amicus separator

Participated in Abili-T clinical trial for treatment of MS for Opexa Therapeutics

Experienced in FDA regulated environment

WOMEN FOR WOMEN OB-GYN Chicago, IL

Medical/Administrative Assistant 2008 2010

Assisted with the in-office surgical procedures (LEEP, biopsies)

At the direction of doctor educated patients about treatment procedures, risk factors and recommendations

NORTHWEST CARDIOVASCULAR CENTER Chicago, IL

Medical/Administrative Assistant 2005 2007

Registered patients, collected health history, vital signs, laboratory specimens, EKG

Instructed patients with doctors recommendations, paperless charts

MOUNT SINAI HOSPITAL Chicago, IL

Emergency Psychiatric Service Specialist 2002 2003

Evaluated emergency psychiatric patients

Provided immediate severity of the problem assessment, early intervention, referral and linkage for patients

presented with acute psychiatric and/or emotional crisis

ST. JOSEPH HOSPITAL Chicago, IL

Research Assistant 1997 1999

Participated in two major research projects: Non-Compliance of Neonatal Follow-up and Evaluation of the

Neonatal Resuscitation Program

Responsible for neonatal growth monitoring and trends assessment

Reported at Neonatal High Risk Follow-up Clinic weekly multidisciplinary meetings

COMMUNITY HOSPITAL Stargard, Poland

Physician 1991 1992

Rotated through Internal Medicine, Pediatric, Surgery and Ob-Gyn Departments

Treated patients at the hospital, Emergency Room and in outpatient clinic

LEADERSHIP & COMMUNITY ENGAGEMENT

POLISH-AMERICAN MEDICAL SOCIETY (PAMS) (Non-for-Profit Organization) Chicago, IL

Member of the Board 2000 2002

Coordinated section and mentored newly immigrated physicians

Organized fundraisers and events for PAMS

Developed guidelines

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