Amy S. Krushelniski, A.A., B.S.

*** * **** ******

Spring Hill, KS 66083

913-***-****

acfyhr@r.postjobfree.com

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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