Regulatory Coordinator - Cancer Center jobs in United States
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University of Kansas Medical Center · 19 hours ago

Regulatory Coordinator - Cancer Center

The University of Kansas Medical Center is the region's only National Cancer Institute-designated comprehensive cancer center offering advanced therapies and clinical trials. The Regulatory Coordinator is responsible for ensuring compliance with regulatory requirements and managing study-specific regulatory and safety reporting across multiple studies.

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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 certificationComputer skillsMultitaskingAnalytical problem-solvingInterpersonal skillsCommunication

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
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Cover Letter

Preferred

Bachelor's degree in relevant field of study
Research certification such as: Certified Clinical Research Coordinator (CCRC); Certified Clinical Research Professional (CCRP); Collaborative Institutional Training Initiative (CITI) training certification or other research certification eligible
Computer skills
Interpersonal skills
Multitasking
Communication
Analytical and problem-solving

Benefits

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.
Employer-paid life insurance, long-term 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.

Company

University of Kansas Medical Center

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The University of Kansas Medical Center strives to educate exceptional health care professionals.

Funding

Current Stage
Late Stage
Total Funding
$27M
Key Investors
Kauffman FoundationNCATS
2024-11-11Grant
2022-09-21Grant· $27M

Leadership Team

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Sean Roberts
Chief Technology Officer
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Chris Harper
Chief Information Officer
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