Regulatory Coordinator - Research Administration

University of Kansas Medical Center•Kansas City, MO

1d•$28 - $38•Onsite

About The Position

The Regulatory Coordinator 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. This position 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.

Requirements

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)

Nice To Haves

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
Organization
Interpersonal skills
Multitasking
Communication and writing skills
Analytical and problem-solving skills.
Time management

Responsibilities

Prepare and submit all regulatory documents including to the Institutional Review Board, collaborate with team members to ensure regulatory documents are complete and accurate.
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 audits
Update 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.

Benefits

health, dental, and vision insurance
health expense accounts with generous employer contributions
Employer-paid life insurance
long-term disability insurance
various additional voluntary insurance plans
Paid time off, including vacation and sick
ten paid holidays
One paid discretionary day is available after six months of employment
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
additional voluntary retirement programs (457 or 403b)