Regulatory Coordinator - 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

Department

RI Office of Clinical Trials Administration (OCTA)

Clinical Coordinating Center Department

Position Title

Regulatory Coordinator - Research Administration

Job Family Group

Professional Staff

Job Description Summary

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.

Key Roles and 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.

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 Qualifications

Work 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)

Education

Bachelor’s degree in relevant field of study

Preferred Qualifications

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 Documents

• Resume
• 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

$58,656.00 - $79,772.00

Minimum

$58,656.00

Midpoint

$69,000.00

Maximum

$79,772.00