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University of Kansas Medical Center · 1 day ago

Regulatory Coordinator - Cancer Center

Kansas City, KS

Full-time

Onsite

Mid Level

$26.13/hr - $39.20/hr

4+ years exp

The University of Kansas Medical Center is a leading institution in cancer research and treatment, and they are seeking a Regulatory Coordinator for their Cancer Center. The role involves ensuring compliance with regulatory requirements and managing study-specific regulatory and safety reporting across multiple studies.

EducationHigher EducationUniversities

Growth Opportunities

Responsibilities

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

Qualification

Clinical research regulationsRegulatory affairs guidelinesMedical terminologyResearch certificationMultidisciplinary teamworkComputer skillsMultitasking skillsAnalytical skillsInterpersonal skillsCommunication skillsProblem-solving skills

Required

4 years of relevant work experience. Education may be substituted 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 medical terminology and concepts

Experience working with multidisciplinary teams

Resume/CV

Cover Letter

Preferred

Bachelor's degree in relevant field of study

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

Computer skills

Interpersonal skills

Multitasking skills

Communication skills

Analytical and problem-solving skills