Process, route, and track regulatory documents for study start-up.Maintain trial master file and/or regulatory binder.Maintain study files for team credentials (GCP Training, CV, Medical License).Provide assistance to study monitors during routine monitor visits or auditsUpdate protocol-specific systems with complete and accurate protocol and study information.Update regulatory documents as assigned: Adding/removing study team members from regulatory documents. Printing, sorting, and filing documents. Updating templates.Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.Ensure activities are conducted in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.Performs job responsibilities in a safe and secure manner. - Ensure coordination of area work with other areas of KUMC to ensure integration and support of KUMC goals and objectives.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required QualificationsWork Experience:- Four years of related work experience. Education may substitute for experience on a year for year basis.
- Experience with regulations governing clinical research (CFR, GCP, HIPAA)
- Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
- Experience with Microsoft Office Suite (Word, Excel, Outlook, Powerpoint)
Preferred QualificationsEducation:Bachelor's degree in relevant field of study
Certifications/Licenses:Research certification preferred such as:- Certified Clinical Research Coordinator (CCRC) or certification eligible
- Certified Clinical Research Professional (CCRP) or certification eligible
- Skills
- Organization
- Interpersonal skills
- Multitasking
- Communication and writing skills
- Analytical and problem-solving skills.
- Time management
Required DocumentsResume
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 ten 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.htmlEmployee Type: Regular
Time Type: Full time
Rate Type: Salary
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: $58,656.00 - $79,772.00
Minimum$58,656.00
Midpoint$69,000.00
Maximum$79,772.00
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---Research-Administration_JR010135 or go to
https://careers.kumc.edu/ and search for position number JR010135.
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 Center's 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.htmlEqual Employment Opportunity Statement
The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. http://policy.ku.edu/IOA/nondiscrimination">http://policy.ku.edu/IOA/nondiscriminationje-673c0689003441cf8bc68d2e3c0eecde
