Clinical Research Manager
Resume:
Michelle Anne Marsicek
Arlington Heights, Illinois 60004
224-***-**** or ********.********@****.***
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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