Nadia Kardegar

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

Milwaukee Wisconsin 53202 Mobile: 513-***-****

ac44z4@r.postjobfree.com

SUMMARY

Dedicated individual seeking to obtain a position in the clinical research and development field where my experience and enthusiasm will have application. My education and professional experience in research has increased my ability to synthesize information and solve complex clinical related issues swiftly and independently.

WORK EXPERIENCE

Contract Clinical Research Associate 2017-present

Coordinate and manage activities as related to the conduct of all phases of medical device clinical trials.

Work closely with investigative sites during the regulatory document process from start-up through close-out phases.

Implement and conduct study planning, execution, monitoring and completion activities.

Conduct study set-up activities - including the development of documents used during the study (such as Delegation of Authority log, Investigator Binder, Source Document Worksheets, Drug/Device Accountability Logs, site recruitment tools, etc.).

Review and assist in negotiations and finalization of Confidentiality Disclosure Agreements and Clinical Trial Agreements.

Review and approve site Informed Consent Forms for submission to site IRBs.

Review protocols and assist and approve Case Report Form design.

Organize and prepare trial related material and presentations for investigator and coordinator meetings. Will present as necessary at investigator and coordinator meetings.

Work with Lead CRA and Sponsor to identify and screen qualifications of potential investigative sites.

Maintain a site and/or investigator selection process.

Train the investigative sites on protocol and procedures.

Provide ongoing site management and monitoring support from study start-up through project completion.

Provide centralized investigative site support, communication and coordination to ensure accurate and timely completion of all contracted activities.

Facilitate general communication among the research centers, project teams, Sponsors, site monitors and vendors relative to the responsibilities itemized above.

Help to resolve issues at investigative sites with the support of other members of the Clinical Project Team.

Assist with managing all "in-house" site related activities, including regional monitor management and monitoring report/expense report review.

Maintain communications on a regular basis with the investigator and/or his/her assigned contact. Lead Clinical Research Associate, Medpace. 2013-2017

Coordinate and manage activities as related to the conduct of all phases of pharmaceutical, biotechnology and medical device clinical trials.

Maintain, update and generate departmental standard operational procedures and guidelines.

Work closely with investigative sites during the regulatory document process from start-up through close-out phases.

Implement and conduct study planning, execution, monitoring and completion activities.

May assist the Regulatory Documents Coordinator with developing and maintaining databases for tracking of regulatory documents, work flow process and other essential trial related documents.

Conduct study set-up activities - including the development of documents used during the study (such as Delegation of Authority log, Investigator Binder, Source Document Worksheets, Drug/Device Accountability Logs, site recruitment tools, etc.).

Review and assist in negotiations and finalization of Confidentiality Disclosure Agreements and Clinical Trial Agreements.

Review and approve site Informed Consent Forms for submission to site IRBs.

Review protocols and assist and approve Case Report Form design.

Organize and prepare trial related material and presentations for investigator and coordinator meetings. Will present as necessary at investigator and coordinator meetings.

Manage and support CRAs working on trials.

Maintain a site and/or investigator selection process.

Train the investigative sites on protocol and procedures.

Provide ongoing site management and monitoring support from study start-up through project completion.

Provide centralized investigative site support, communication and coordination to ensure accurate and timely completion of all contracted activities.

Facilitate general communication among the research centers, project teams, Sponsors, site monitors and vendors relative to the responsibilities itemized above.

Perform all types of monitoring visits according to Medpace SOPs.

Help to resolve issues at investigative sites with the support of other members of the Clinical Project Team.

Assist with managing all "in-house" site related activities, including regional monitor management and monitoring report/expense report review.

Maintain communications on a regular basis with the investigator and/or his/her assigned contact.

Set up, populate and maintain the clinical trial monitoring/management tracking systems. Clinical Project Coordinator, Medpace, 2012-2014

Provide insightful input on clinical trial related documents (study protocol, data analysis plan, final study report, etc.)

Utilize and maintain project management databases (site supplies, site contacts)

Compile and maintain clinical trial status reports

Maintain site payment schedule

Create and maintain project timelines

Independently interact with the sponsor, study centers, other contractors, and Medpace team

Ensure all necessary project documents are collected and finalized Adjunct Faculty, Sinclair Community College, 2009-2014

Taught several Anatomy and Physiology courses, Developed individual education plans, Developed an ability to inspire students and convey educational concepts through innovative approaches and instruction Adjunct Faculty, Xavier University, 2013-2014

Taught Anatomy and Physiology Lab

Laboratory Director, Sinclair Community College, 2009-2012

Directed and managed laboratory activities for all science courses

Assisted College Dean with strategies for course development and laboratory activities

Identified areas of opportunity and proposed cost saving projects Adjunct Faculty, Cincinnati States/Sinclair Community College, 2011-2012

Taught Biotechnology course

Developed curriculum for Bioscience course offered by BioOhio workforce development.

Taught Quality Control and Cleanroom Operational skills and Aseptic 101.

Demonstrated leadership skills and proven ability to motivate and mentor students of all ages and learning levels RESEARCH EXPERIENCE

Research Assistant, Neuroscience & Psychology Department, Wright State University, 2008-2012

Assisted 3 studies of the relation between neuroendocrine activity and behavior, particularly during development. Utilized variety of techniques such as Necropsy and Aseptic Rodent Surgery, Gelatin Embedding, Histology, Perfusion, and Statistical analysis. Performed research on Early-life Psychological Stressors and their influence on Depressive-like behavior and development of Depressive illness in adulthood.

Research and Neuroscience Department Assistant, University of Cincinnati, 2007-2008

Assisted graduate students with projects and utilized laboratory skills Pathology Department Assistant, University of Cincinnati, 2004-2008

Assisted with Rodent Surgery, Lung and Colon Cancer Research. Managed and conducted Necropsy for all of the operating research laboratories at College of Medicine. IACUC trained and certified for animal use EDUCATION AND CREDENTIALS

BS. Biology-2008 University of Cincinnati

BS. Chemistry-2008 University of Cincinnati

M.S. Anatomy-2012 Wright State University

ACTIVITIES

Vice President of Programming & Volunteering, Pre-Med Society, 2003-2007

Vice President of Persian Student Association, 05-2008

Board Member of the Cincinnati Persian Event Planners, 2011-Present AWARDS

Proctor and Gamble Scholarship (2 Awards, 500 applicants)

Wright State Graduate Scholarship (5 Awards, 30 applicants) PUBLICATION

Dragana I Claflin, Patricia A. Schiml, Nadia Kardegar, Jennifer Caudill, Riaun Floyd, Terrence Deak, Jaak Panksepp, Michael B. Hennessy; “Responses of guinea pigs to brain stimulation during isolation: Examining the transition from “protest” to depressive- like behavior”, Neurology, Psychiatry and Brain Research

Contact this candidate