Project Manager Quality Assurance
Resume:
Michelle Rae Miller, CCRP
***** **** **** ******, ************, MO 64055
abi3kz@r.postjobfree.com
SKILLS SUMMARY
More than 8 years of experience in Research/Regulatory Compliance in the
Human Research Protection field including 3 years experience of IRB
administration in an Oncology Program setting and 2 years experience in
Project Management. Strong research compliance/regulatory background with
the ability to communicate efficiently and effectively with physicians,
patients, & Government agencies. Ability to create a pleasant working
environment for co-workers while ensuring work is completed in a timely &
organized manner.
EXPERIENCE
Quintiles, Overland Park, KS 8/10 to
present
Site Start-up Coordinator
< Assists with preparation and distribution of regulatory
documents to sites; tracks progress of such documents within
required systems.
< Central contact for investigative sites
< Manages data tracking entries into designated clinical tracking
systems in accordance with project requirements.
< Distributes completed documents to sites and internal project
team members as instructed.
< Assists in the preparation and distribution of internal
documentation and reports as required.
< Assists designated team members with preparing submissions for
Institutional Review Boards (IRB), by compiling the package of
documents for the IRB and forwarding it to either the
Investigator or IRB as directed.
< Prepares and maintains the regulatory binders (sites and in-
house), during start up period, as per the applicable SOPs.
Kansas City Clinical Oncology Program, Kansas City, MO
8/07 to present
Institutional Review Board (IRB) Administrator, Human Research
Protection Program
< Organize multiple activities with numerous professionals along
with preparing materials for deadlines
< Review & prepare cancer related research protocols
< Assessing patient/subject consent forms
< Database building, entry & maintenance
< Remaining in constant contact with investigators & research
assistants regarding events relating to the protocol
< Design and create forms and applications for the submission of
research proposals
< Create & prepare the file folders according to regulations
< Construct policies & procedures that uphold the rules &
regulations that fall under the Code of Federal Regulations &
the Belmont Report
< Remain in constant contact with the office of Human Research
Protections (OHRP), & National Institutes of Health (NIH)
regarding our status as an ethics committee under the Federal
Wide Assurance (FWA) program
< Staying up to date on the always changing rules & regulations
that pertain to IRB's such as; Conflict of Interest issues, Data
Safety & Monitoring Committee's, HIPAA & Personal Health
Information (PHI), & Human Research Protection Program (HRPP)
updates
< Maintaining the organization of the office, the committee, & its
Investigators
University of Kansas Medical Center, Research Institute, Kansas City,
KS 5/09 to 8/10
Clinical Trials Project Manager
< Developing contracts and subject enrollment strategies to
minimize costs and stay on budget
< Review research protocols and prepare study specific consent
forms. Specialized in Phase I Neurology studies with emphasis on
Parkinson's Disease, Multiple Sclerosis, Alzheimer's, and
Huntington's Disease, as well as Emergency Medicine, Psychiatry,
Cardiovascular Diseases, Infectious Diseases, Pediatrics,
Dietetics and Nutrition, and Internal Medicine. Also serve as a
back up to all other project managers assigned in other disease
groups.
< Assembling and lead the clinical trial team and conduct
effective team meetings to model good communication practices
throughout the trial
< Utilizing proven audit techniques to establish a practical
approach for maintaining regulatory compliance
< Implementing best practices for managing misconduct and fraud to
protect patient safety and avoid costly regulatory and legal
action
< Developing efficient processes for data management and adverse
event reporting to streamline compliance requirements
< Utilizing proven quality control tools to collect and measure
performance data and implement process improvements
< Identifying and prioritize financial, technical, and legal risks
to ensure project success
< Ensure that protocols, amendments, adverse event reports,
investigational drug brochures, continuing reviews and other
miscellaneous documents are approved by the Human Subjects
Committee (HSC), hospital departments/committees, appropriate
federal and regulatory oversight groups, as appropriate.
< Maintain records and files in accordance with regulatory
requirements. Ensure that all data is entered into the
departmental database in a timely and accurate fashion.
< Prepare and maintain regulatory documents.
< Serve as the primary contact person for principal investigators,
sponsors, HSC and contract research organizations.
< Administer internal documentation of a clinical trial.
< Participate in special projects/events promoting clinical trials
to the appropriate parties.
< Participate in research education opportunities.
Ethical Review Committee, Independence, MO 2/08
to 5/09
Regulatory Compliance /Quality Assurance / Education Administrator
< Design and create forms and applications for the submission of
research proposals
< Initiated and created the only State-by-State clinical trial
requirements database including 21 different categories of
regulations that pertain to human subjects research
< Reviewing all intake and outtake for individual State and
Federal regulatory requirements
< Assessing patient/subject consent forms
< Develop training tools and assessments for IRB staff, members,
and participating Investigators
< Database building, entry & maintenance
< Construct policies & procedures that uphold the rules &
regulations that fall under the Code of Federal Regulations,
Federal Drug Administration & the Belmont Report
< Staying up to date on the always changing rules & regulations
that pertain to IRB's such as; Conflict of Interest issues, Data
Safety & Monitoring Committee's, HIPAA & Personal Health
Information (PHI), & Human Research Protection Program (HRPP)
updates
University of Kansas Medical Center*, Kansas City, KS
6/04 to 8/07
IRB Coordinator, Research Compliance/Human Research Protection
Program (*Accredited Institution)
< Organize multiple activities with numerous professionals along
with preparing materials for deadlines
< Review & prepare medical and educational research protocols
< Assessing patient/subject consent forms
< Database entry & maintenance
< Remaining in constant contact with investigators & research
assistants regarding events relating to the protocol
< Create & prepare the file folders according to regulations
< Conduct internal performance audits
< Assist in construction of policies & procedures that uphold the
rules & regulations that fall under the Code of Federal
Regulations, Federal Drug Administration & the Belmont Report
< Staying up to date on the always changing rules & regulations
that pertain to IRB's such as; Conflict of Interest issues, Data
Safety & Monitoring Committee's, HIPAA & Personal Health
Information (PHI), & Human Research Protection Program (HRPP)
updates
< Maintaining the organization of the office, the committee, & its
Investigators
< Ordering supplies when needed
< Answering a multiple line phone system
EDUCATION & TRAINING
Metropolitan Community College, Kansas City, MO
1/07 to 5/07
< Business Administration
Park University, Parkville, MO
8/05 to 5/06
< Criminal Justice~ Criminal Law
< Foreign Language~ Spanish
Missouri Western State University, Saint Joseph, MO 8/00
to 5/01 returned 8/02 to 5/03
< Business Administration
Hillyards Technical Center, Saint Joseph, MO
12/01 to 2/02
< Certified Nurses Assistant (CNA)
Lafayette High School, Saint Joseph, MO
2000 Graduate
< Graduated in the top %10 in a class of 187
Clinical Trials Education Lecture Series
4/05 to 8/10
Clinical Research Professional Certification (CCRP)
12/09
IRB 201~6.25 CME Credit Hours
11/08
2008 Advancing Ethical Research Conference~ 22.25 CME Credit Hours
11/08
IRB 101~ 6 CME Credit Hours
2/08
IRB Administrator 101~ 9.5 CME Credit Hours
2/08
HIPAA Education/Lectures w/Training
5/07
Microsoft Office Fundamentals
5/07
AWARDS & VOLUNTEERING
Susan G. Komen Autism Now Member Autism Walk Participant
Participant
Heart Walk Participant MS Walk Community Service Team Lead
Participant
KU Parking Committee PRIM&R Mentor PRIM&R Volunteer of the
Month, July 09
Contact this candidate