Project Manager Management
Resume:
Amy S. Krushelniski, A.A., B.S.
Spring Hill, KS 66083
**********@*******.***
Summary of Qualifications
Ms. Krushelniski's management, regulatory, financial and laboratory
experience includes working as a Clinical Trials Budget Analyst, Regulatory
Specialist, and Clinical Project Manager. She has also held positions as a
Research Laboratory Technician and a Laboratory General Supervisor in both
hospital and industry settings.
Professional Experience
Quintiles
Overland Park, KS
07/2013-present
Prime Site Study Start-Up Specialist
Responsible for performing tasks at country level associated with
Regulatory, Start-up (RSU) and Maintenance activities in accordance with
applicable local and/or international regulations, standard operating
procedures (SOPs), project requirements and contractual/budgetary
guidelines.
University of Kansas Cancer Center
Fairway, KS
Study Budget Analyst
03/08/2013-06/20/2013 (fiscally non-reappointed by the state of Kansas)
Responsible for preparing, maintaining, and negotiating budgets related to
clinical trial activities. Reviewed clinical trial contracts for routine
changes and negotiated Clinical Trial Agreements (CTAs) with sponsors.
Worked in conjunction with other divisions, as well as representatives from
other institutions of higher education, sponsors, attorneys, governmental
entities, philanthropic organizations and principal investigators as a
necessary function of the job.
Kansas City Clinical Oncology Program
Prairie Village, KS 66208
Regulatory Coordinator/ Drug Specialist
05/2009 to 03/2013
Assist director in the planning of all SOPs and regulatory affairs.
Function completely independently as a decision-maker on regulatory issues,
and must assure all deadlines are met. Effectively communicate, prepare,
and negotiate both internally and externally with various regulatory
agencies. Properly interpret and apply regulatory requirements.
Independently run the regulatory department to ensure efficient and
compliant business processes. All work is performed without appreciable
direction. Monitor the impact of changing regulations on submission
strategies. Monitor and submit applicable reports and ensure appropriate
responses are submitted to regulatory authorities. Negotiate and interact
with regulatory authorities during development and review process to ensure
submission approval. Review and approve advertising and/or promotional
items for regulatory compliance.
UBC Late Stage Group
Kansas City, MO
Project Manager
08/2006 to 05/2009
Ms. Krushelniski was responsible for operating as an independent Project
Manager in all study-related items in a clinical trial according to company
and/or project-specific SOP's, guidelines, budgets and contracts. These
include anticipating and resolving project issues; ensuring case report
forms meet the project's needs; assisting in protocol development;
coordinating investigator meeting; preparing project timelines; locating
appropriate investigators and assist in negotiating budgets/clinical study
agreements; preparing documents for IRB and FDA submission, as necessary;
ensuring completion of final and interim reports required by sponsor;
working knowledge of contract; ensure the Study Master File is developed
and maintained; assign and supervise all employee activities.
Clinical Research Associate I/II
09/2003 to 08/2006
Ms. Krushelniski was responsible for assisting the project team in the
management of clinical trials according to project and company-specific
SOP's and guidelines. Duties included corresponding with sites to boost
enrollment; conducting training on protocol and study procedures;
contacting sites weekly to provide management and support; collecting
regulatory documents; and resolving all data queries. Duties also included
reviewing CRF's for completeness and accuracy, interfacing with the data
management department, and ensuring the satisfactory completion of
documentation and turnaround time for response to serious adverse events.
University of Kansas Medical Center
Kansas City, KS
Reproductive Endocrinology Laboratory, General Supervisor
01/2000 to 07/2003
Ms. Krushelniski was responsible for the daily operation of the endocrine
and embryology laboratories. She supervised the laboratory staff and the
performance of professional laboratory testing. She utilized her expertise
in endocrinology, embryology, phlebotomy, and ICSI. Ms. McProud
facilitated the delivery of optimum laboratory results, prepared study
specimens, as well as coordinated and documented clinical trials. In
addition, she provided round-the-clock, on-call supervision of human
gametes and embryos.
Education
Kansas State University, Manhattan, KS
Bachelor of Science - Fisheries and Wildlife Biology 1999
Kansas State University, Manhattan, KS
Bachelor of Science - Natural Resources and Environmental Science 1998
Johnson County Community College, Overland Park, KS
Associate of Arts Degree - Liberal Arts 1996
Conferences Attended/Continuing Education
Who's Who of Professional Women elected member 2008
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