Regulatory Coordinator- Psychiatry and Behavioral Sciences

University of Kansas Medical Center Kansas City, KS Full-time Science

Posted on April 23, 2024

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Regulatory Coordinator- Psychiatry and Behavioral Sciences

Department:
SOM KC Psychiatry & Behavior Sciences
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Administration

Position Title:
Regulatory Coordinator- Psychiatry and Behavioral Sciences

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: Associates 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:

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.

Preferred Qualifications

Education/Certification:

- Bachelor's degree in relevant field of study.

- Research certification preferred such as,

Certified Clinical Research Coordinator (CCRC) (or certification eligible) or,
Certified Clinical Research Professional (CCRP) or certification eligible

Skills:

Ability to effectively work in multidisciplinary teams;
Demonstrated ability to work independently with moderate direct supervision;
Demonstrated ability to multitask

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 development 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.
Update protocol-specific systems with complete and accurate protocol and study information.
Assure 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

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.html

Employee 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:
$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--Psychiatry-and-Behavioral-Sciences_JR006964 or go to https://careers.kumc.edu/ and search for position number JR006964.

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.html

Equal 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

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