Michelle Anne Marsicek

**** *. ******* *****

Arlington Heights, Illinois 60004

224-***-**** or acsqdo@r.postjobfree.com

EXPERIENCE

US Oncology, Niles, Illinois and Arlington Heights, Illinois

Clinical Research Coordinator, March 2015 to present

Enlisting and maintaining patients on research protocol regimens

Collaborating with physicians in determining eligibility of patients for clinical trials and actively screening for potential study participants

Providing education to nursing staff at monthly meetings on protocol and GCP and subsequent protocol compliance

Presenting trial concepts and details to the patients and participating in the informed consent process

Processing genetic tests such as Foundation One

Coordinating of scheduling of tests and treatments required for the protocol

Ensuring accurate and complete data collection, entry, and timely submission to central operations in accordance with SOPs

Assessing patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and thoroughly documenting all findings

Meeting with monitors for routine monitoring visits and following up on query responses

Conducting ECOG cooperative group research trials

Clinical Research Data Coordinator, September 2014 to March 2015

Prepared data submission for the Quality Oncology Practice Initiative (QOPI) certification process

Created documents for practice for Blue Cross ACO process

Maintained transplant patient data and answered queries for the National Marrow Bone Donor Program Registry

Extrapolated data, completed case report forms, and ensured timely data submission for Phase II-IV clinical trials

Collected and processed specimens, imaging documents, or other items required for research purposes

Maintained research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines and any other applicable regulations

Ensured that all queries are resolved in a timely manner in accordance with USOR SOPs and sponsor requirements

Self-Employed

Grant Writer and Non for Profit Program Consultant, May 2008 to present

Preparation and submission of government and foundation grants

Development of non for profit programming

Research and consultation on funding sources

Creation of non-profit entities

Parent advocate for children with disabilities

Blog writing for healthcare grant writing

Web and content development for joyofmom.com

Non-Fiction Writer

Authoring and illustrating children’s books on healthcare topics

Ballard Healthcare, Des Plaines, Illinois

Grant Writer and Clinical Researcher, December 2007 to May 2010

Preparation and submission of government and foundation grants

Presentation of grant programs at professional meetings

Publication of heathcare journal articles

Creation and management of grant databases

Formation of new grant programs to fund

Management of satisfaction surveys

Creation of a non-profit entity

The InGenius Center, Arlington Heights, Illinois

Casewriter and Training Manager as an independent contractor, April 2000 to April 2002

Interviewed clients on the phone

Assessed client’s motivational abilities and generating web based reports

Trained other casewriters and monitored their work

Children’s Brain Tumor Foundation, Lutheran General Hospital, Park Ridge, Illinois

Clinical Research Coordinator as an independent contractor, March 2001 to September 2001

Worked on designing a trial in the field of pediatric brain cancer imaging

Researched background information for pediatric brain cancer trial

Regency Medical Center, P.C., Palatine, Illinois

Clinical Research Coordinator as an independent contractor, March 2000 to October 2000

Coordinated clinical research studies in rheumatology

Monitored subject’s progress and completed subsequent paperwork

Prepared regulatory documentation for studies

Quantum Clinical Research, A division of Advocate Medical Group, Chicago, Illinois

Clinical Research Coordinator, February 1999 to September 1999

Clinical Research Coordinator as an independent contractor, June 1998 to February 1999

Coordinated phase II, III, and IV clinical research studies in behavioral health, cardiology, gynecology, internal medicine, pediatrics, and rheumatology

Monitored subject’s progress and completed subsequent paperwork

Prepared regulatory documentation for studies

Trained subjects in the use of electronic diaries via a self-designed internet presentation

Instructed coordinators in the use of GCP and CRF completion at an investigator meeting

Monitored work of coordinators through quality assurance

Created Standard Operating Procedures for all trials

Scirex, Bloomingdale, Illinois

Team Leader, November 1997 to February 1998

Audited Studies for good documentation and accuracy

Responsible for the successful completion of studies of all phases

Supervised team members in processing of study data

Designed data entry screens and manuals for team studies

Worked on implementation of new system for work flow in the department

Advanced Resources, Deerfield, Illinois

Study Coordinator as a Data Mgmt Consultant at Abbott Labs, April 1997 to November 1997

Designed case report forms for sites

Created schema for data entry

Piloted faxing plan for data retrieval

Maintained clean study data by querying research sites

Wrote programs which target incomplete or inconsistent data

Presented CRF completion guidelines at investigator’s meetings

Rheumatology Associates, Rush Presbyterian St. Luke’s Hospital, Chicago, IL

Clinical Research Coordinator, April 1996 to April 1997

Maintained patient data in pharmaceutical studies within FDA guidelines

Performed patient monitoring and screening visits

Solicited new pharmaceutical studies and submitted them to the IRB

Implemented systems for the tracking of patient visit data

Functioned as primary contact with sponsor

Developed database for practice patient visits for academic research

Northwest Community Hospital, Arlington Heights, Illinois

Pharmacy Technician, April 1993 to April 1997

Filled prescriptions in inpatient and outpatient setting

Implemented return system for the hospital

Americair Home Care, Rosemont, Illinois

Office Manager, November 1992 to April 1993

Monitored patient care

Tracked patient information called in by medical representatives

Medical Representative, July 1992 to November 1992

Provided information on respiratory care to physicians

Promoted to office manager within five months

EDUCATION

The University of Illinois at Chicago, January 1992 to December 1996

Bachelors of Science in Biological Sciences

Computer Skills: Windows 8, Office Suite, Adobe Photoshop, HTML, CSS, Dreamweaver, iKnowMed, Rave,

iMeditata, inForm, Bracket, Clinphone, Perceptive, Endpoint, Perceptive, Bracket

VOLUNTEER EXPERIENCE

Operation Bunny

Sole Coordinator of collection of 6400 stuffed bunnies in 12 days for the families of the troops

overseas in Iraq

RESOLVE of Illinois

Database Coordinator, Special Events Committee, PR and Fundraising Committee, Weekly

Help line Counselor, Pregnancy Support Group Co-coordinator

Mothers and More

Public Relations Board Member Position, Party Planner

Saint James Preschool of Religion

Craft Team Manager

Ivy Hill PTA

Newsletter Editor, Art Awareness Educator, Room Representative, theater set designer,

theater script writer

Westgate School PTA

Art Awareness Educator, Room Representative, newsletter editor

Cove School for Learning Disabilities

Volunteer for Benefits Committee

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