Regulatory Coordinator Job at University of Kansas Medical Center
Department:
SOM KC Urology
-----
Lee Lab
Position Title:
Regulatory Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for performing study-specific regulatory and safety reporting across multiple studies. 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:
Required Qualifications:
Education : Associate's degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals 4 years.
Work Experience : 4 years relevant work experience
Skills : Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Understanding of statutes and guidelines relevant to regulatory affairs in clinical research. Working knowledge of Microsoft Office Suite. Ability to effectively work in multidisciplinary teams. Demonstrated ability to work independently with moderate direct supervision. Demonstrated ability to multitask.
Preferred Qualifications:
Education : Bachelor's degree in relevant field of study. Research certification preferred such as:
Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible
Job Duties Outlined:
Serves as the assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenance of regulatory records throughout the life of an assigned protocol.
Prepare/develop and make submission of all regulatory documents including submission of study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate.
Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.
Maintain trial master file and/or regulatory binder. Maintain regulatory records throughout the life of the study.
If applicable, provide assistance to study monitors during routine monitor visits or audits.
If applicable, provide assistance to study monitors during routine monitor visits or audits.
Update protocol-specific systems with complete and accurate protocol and study information.
Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.
Assure that all tasks necessary for study activation have been completed and communicate, coordinate and collaborate with central administration and others regarding the activation process.
Other relevant duties as requested by the supervisor.
Required Documents:
Resume/CV
Cover Letter
Employee Type:
Fixed Term (Fixed Term)
Time Type:
Full time
Rate Type:
Hourly
Pay Range:
$54,000.00 - $80,000.00
Minimum
$54,000.00
Midpoint
$67,000.00
Maximum
$80,000.00
Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Regulatory-Coordinator_JR003336 or go to https://careers.kumc.edu/ and search for position number JR003336.
Applications 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.
About KU Medical Center:
The 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 .
Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html
KU is an EO/AAE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, genetic information or protected Veteran status. http://policy.ku.edu/IOA/nondiscrimination
jeid-a30e872f9cf32d468710c68e0a4e61b4
Please Note :
blog.nvalabs.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blog.nvalabs.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
SOM KC Urology
-----
Lee Lab
Position Title:
Regulatory Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for performing study-specific regulatory and safety reporting across multiple studies. 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:
Required Qualifications:
Education : Associate's degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals 4 years.
Work Experience : 4 years relevant work experience
Skills : Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Understanding of statutes and guidelines relevant to regulatory affairs in clinical research. Working knowledge of Microsoft Office Suite. Ability to effectively work in multidisciplinary teams. Demonstrated ability to work independently with moderate direct supervision. Demonstrated ability to multitask.
Preferred Qualifications:
Education : Bachelor's degree in relevant field of study. Research certification preferred such as:
Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible
Job Duties Outlined:
Serves as the assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenance of regulatory records throughout the life of an assigned protocol.
Prepare/develop and make submission of all regulatory documents including submission of study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate.
Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.
Maintain trial master file and/or regulatory binder. Maintain regulatory records throughout the life of the study.
If applicable, provide assistance to study monitors during routine monitor visits or audits.
If applicable, provide assistance to study monitors during routine monitor visits or audits.
Update protocol-specific systems with complete and accurate protocol and study information.
Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.
Assure that all tasks necessary for study activation have been completed and communicate, coordinate and collaborate with central administration and others regarding the activation process.
Other relevant duties as requested by the supervisor.
Required Documents:
Resume/CV
Cover Letter
Employee Type:
Fixed Term (Fixed Term)
Time Type:
Full time
Rate Type:
Hourly
Pay Range:
$54,000.00 - $80,000.00
Minimum
$54,000.00
Midpoint
$67,000.00
Maximum
$80,000.00
Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Regulatory-Coordinator_JR003336 or go to https://careers.kumc.edu/ and search for position number JR003336.
Applications 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.
About KU Medical Center:
The 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 .
Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html
KU is an EO/AAE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, genetic information or protected Veteran status. http://policy.ku.edu/IOA/nondiscrimination
jeid-a30e872f9cf32d468710c68e0a4e61b4
Please Note :
blog.nvalabs.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blog.nvalabs.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.