Department:

SOM KC Cancer Center Clinical Trials

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Regulatory Affairs

Position Title:

Regulatory Coordinator - Cancer Center

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 will be the 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:

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.

• 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.

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:

Education:

• Associate’s degree plus two years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals 4 years. 

• Education may be substituted for experience 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 with medical terminology and concepts.

• Experience working with multidisciplinary teams.

Preferred Qualifications:

Education:

• Bachelor’s degree in relevant field of study.

Certification:

• Research certification 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.

Skills:

• Computer skills including the Microsoft Office Suite.

• Interpersonal skills.

• Multitasking.

• Communication.

• Analytical and problem-solving skills.

Required Documents:

• Resume/CV

• Cover Letter

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