Regulatory Coordinator, Clinical Research Administration

University of Kansas Medical Center; Kansas City (KS); On-site; USD 59,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement plan (457/403b)

Job summary

The University of Kansas Medical Center is seeking a Regulatory Coordinator in the RI Office of Clinical Trials Administration to manage study-wide regulatory and safety reporting across multiple protocols. You will ensure compliance with CFR, GCP, HIPAA and KU policies while serving as the primary contact for IRB submissions and maintenance of regulatory records.

Responsibilities include preparing regulatory documents, tracking submissions, maintaining the trial master file, coordinating with

Qualifications

• 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)

Responsibilities

• Prepare and submit 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.

Skills

Regulatory knowledge

MS Office Suite

Education

Bachelor’s degree in relevant field

Tools

Microsoft Office Suite

Job description

The University of Kansas Medical Center is seeking a Regulatory Coordinator in the RI Office of Clinical Trials Administration to manage study-wide regulatory and safety reporting across multiple protocols. You will ensure compliance with CFR, GCP, HIPAA and KU policies while serving as the primary contact for IRB submissions and maintenance of regulatory records.

Responsibilities include preparing regulatory documents, tracking submissions, maintaining the trial master file, coordinating with