Department:
RSC SOM Wichita Center for Clinical Research CCR
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Center for Clinical Research Staff
Position Title:
Regulatory Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for regulatory activities in support of clinical research within the KU School of Medicine - Wichita Center for Clinical Research (CCR). This will be accomplished by: assuring that the clinical research is compliant with applicable institutional, federal, state or international requirements. This position will provide support for assigned protocols to include study start up activities and maintenance of regulatory records throughout the life of each assigned protocol.
A resume and cover letter are required to be considered for this position.
Job Description:
Required Qualifications:
Bachelor's degree in a science or health related field, or 2 years full time research experience.
Preferred Qualifications:
Up to 2 years' experience in the regulatory affairs of clinical research.
SoCRA, CCRC, or CCRP certified.
Excellent written and oral communication skills.
Working knowledge of Microsoft software suite.
Demonstrated ability to work independently.
Ability to effectively work in multidisciplinary teams.
Must be detail oriented and have proven ability to multitask.
Job Duties Outlined:
Prepare and file all required clinical trial regulatory documents.
Compile, review, and submit trial documents to the Institutional Review Board as required.
Revise the study's informed consent form(s) as needed per protocol.
Maintain study file documents according to requirements of the U.S. Code of Federal Regulations, ICH GCP, and U.S. FDA guidance.
Interface with study sponsors, study team members and central research administration staff during study conduct regarding regulatory documents or other regulatory issues. Provide updates as required.
Update study information into the Clinical Trial Management System (Velos) for team collaboration.
Submit study documents through the IRB eCompliance portal.
Maintain study documents in the Complion system.
Maintain study documents on the research shared drive.
Provide assistance to file reviewers during monitoring visits or audits.
Attend regularly scheduled department staff meetings.
Provide workload reporting as required by management.
Assist the Research Manager during the study start-up submission process by preparing required regulatory documents. Assist with documentation of study teams, or other associated tasks.
Other duties as assigned.
Required Documents:
Resume/CV
Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus nine paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html
Employee Type:
Regular
Time Type:
Full time
Rate Type:
Hourly
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:
$26.13 - $39.20
Minimum
$26.13
Midpoint
$32.67
Maximum
$39.20
Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Wichita-KS/Regulatory-Coordinator_JR005808 or go to https://careers.kumc.edu/ and search for position number JR005808.
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
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