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Regulatory Coordinator

Posted: 09/11/2022

This position 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 cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

We offer a comprehensive benefits package: Health, dental, vision (effective day 1), employer paid life, LTD, flexible benefits plan, miscellaneous voluntary plans available, paid vacation and sick (begin accruing upon hire), paid holidays, paid discretionary day, paid bereavement leave, paid jury duty, military leave, paid parental leave, retirement plan. 

Starting salary will be between the minimum and midpoint of the range listed for this position.

Required Qualifications:

  • 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. 
  • Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
  • Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
  • Excellent communication, interpersonal, analytical and problem-solving skills.
  • Working knowledge of Microsoft Office Suite
  • Knowledge of medical terminology and concepts
  • Ability to effectively work in multidisciplinary teams.
  • Demonstrated ability to work independently with moderate direct supervision
  • Demonstrated ability to multitask

Preferred Qualifications:

  • 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; Collaborative Institutional Training Initiative (CITI) training certification or certification eligible

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:
  • Resume/CV & Cover Letter

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