Department:

SOM KC Cancer Center Clinical Trials

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Regulatory Affairs

Position Title:

Regulatory Coordinator

Job Family Group:

Professional Staff

Job Description Summary:

Job Description:

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.  Assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life of an assigned protocol.

The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

*This position may be eligible for a hybrid work schedule after 6 months. Incumbent will work remotely and on campus based on a set departmental schedule based on management approval.*

Required Qualifications:

Education:  Bachelor’s degree in relevant field of study. Relevant experience may be substituted for degree on a year-for- year basis.

Work Experience:

• Experience with regulations governing clinical research (CFR, GCP, HIPAA).

• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.

• Experience using the Microsoft Office Suite.

• Experience with medical terminology and concepts.

Preferred Qualifications:

Education/Certifications:

• Research certification preferred such as: Certified Clinical Research Coordinator (CCRC) or certification eligible; Certified Clinical Research Professional (CCRP) or certification eligible; Collaborative Institutional Training Initiative (CITI) training certification or other research certification eligible.

Work Experience:

• Experience working independently.

Skills:

• Excellent communication, interpersonal, analytical and problem-solving skills.

• Multitasking skills.

Job Duties Outlined:

• 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. Maintain trial master file and/or regulatory binder.

• If applicable, provide assistance to study monitors during routine monitor visits or audits.

• Maintain regulatory records throughout the life of the trial to include: submission of all study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate. 

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

• Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.

• Other relevant duties as requested by the supervisor.

Required Documents:

• Cover Letter AND Resume/CV

The University of Kansas Medical Center and The University of Kansas Cancer Center are committed to creating and maintaining a diverse and inclusive learning and working environment, one that nurtures growth and development for all. 

Comprehensive Benefits Package:

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Hourly

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:

$26.13 - $39.20

Minimum

$26.13

Midpoint

$32.67

Maximum

$39.20