Regulatory Coordinator - Cancer Center
Regulatory Coordinator - Cancer Center
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Job Description
Department:
SOM KC Cancer Center Clinical TrialsRegulatory AffairsPosition Title:
Regulatory Coordinator Cancer CenterJob Family Group:
Professional StaffJob Description Summary:
The Regulatory Coordinator is responsible for performing studyspecific 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 studystart 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 regions only National Cancer Institutedesignated comprehensive cancer center where patients gain access to the most promising therapies cuttingedge 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 and must reside in the greater Kansas City metropolitan area.*
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 protocolspecific 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:Associates degree or an equivalent combination of relevant postsecondary education and work experience that equals 2 years.
Work Experience:
2 years of related work experience.
Experience with regulations governing clinical research (CFR GCP HIPAA).
Experience with statutes and guidelinesrelevant to regulatory affairs in clinical research.
Experience using the Microsoft Office Suite.
Experience with medical terminology and concepts.
Preferred Qualifications
Education:Bachelors degree in relevant field of study.
Certification:
Certified Clinical Research Coordinator (CCRC) or certification eligible; Certified Clinical Research Professional (CCRP) or certification eligible; or other research certification eligible.
Skills
Attention to detail.
Analytical/problemsolving skills.
Multitasking/collaboration skills.
Verbal and written communication skills.
Required Documents
Cover Letter
Resume/CV
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. Employerpaid life insurance longterm 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. Type: Regular 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. Minimum Midpoint MaximumTime Type:
Full timeRate Type:
HourlyPay Range:
$26.13 $39.20
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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