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University of Kansas Medical Center Senior Regulatory Coordinator in Kansas City, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/ada/r/jobs/11524530

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rSenior Regulatory Coordinator

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Department:

SOM KC Cancer Center Clinical Trials

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Regulatory Affairs


Position Title:

Senior Regulatory Coordinator


Job Family Group:

Professional Staff


Job Description Summary:

This position is responsible for leading and performing study-specific regulatory and study-specific regulatory and safety reporting for a group of investigators, department or division. This will be accomplished by: assuring the research is compliant with applicable federal, state or international requirements, while adhering to policies of the University of Kansas Medical Center. Assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life of an assigned protocol.


Job Description:


This position is responsible for leading and performing study-specific regulatory and study-specific regulatory and safety reporting for a group of investigators, department or division. This will be accomplished by: assuring the research is compliant with applicable federal, state or international requirements, while adhering to policies of the University of Kansas Medical Center. Assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life of an assigned protocol.


The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.


Starting salary will be between the minimum and midpoint of the range listed for this position.


Required Qualifications:


+ Education: Associate's degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals 8 years.


+ Skills: Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research.




Preferred Qualifications:


+ Education: Master's degree plus two years relevant work experience


Job Duties Outlined:


+ Maintain regulatory records throughout the life of the trial to include: submission of all study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate. Oversee the trial master file and/or regulatory binder.


+ Provide assistance to study monitors during routine monitor visits or audits.


+ Update protocol-specific systems with protocol and study-related information.


+ Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.


+ Serves as a mentor to junior regulatory coordinators. May assign, review, and train others in various work responsibilities and provide constructive feedback to other team members.


+ Perform other duties as assigned.


Required Documents:


+ Resume/CV & Cover letter


Employee Type:

Regular


Time Type:

Full time


Pay Rate Type:

Hourly


Pay Grade:

A11


Pay Range:


Minimum

51348

Midpoint

65352

Maximum

79356

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rApplication Instructions:

rTo learn more and apply online, lease visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Senior-Regulatory-Coordinator\_JR001850 (https://apptrkr.com/2294888) or go to https://careers.kumc.edu/ and search for position number JR001850.

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rApplications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.

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rAbout KU Medical Center:

rThe University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu.

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rBenefits:

rKU Medical Center proudly offers a competitive and comprehensive benefits package through the state of Kansas, with flexible options designed to meet the diverse needs of our faculty and staff. To learn more about our options for medical, vision, dental and other insurances, as well as our generous time off

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