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Saint Luke's · 3 hours ago

Research Regulatory Specialist

Kansas City, MO

Full-time

Hybrid

Mid Level

3+ years exp

Saint Luke's is a nonprofit health system in Kansas City, committed to excellence in patient care. The Research Regulatory Specialist will oversee research administration activities for clinical trials, ensuring compliance with regulations and serving as the primary contact for regulatory support.

Health CareHealth DiagnosticsHospitalNon Profit

Responsibilities

Responsible for all research administration activities of assigned clinical trials for Regulatory Support of Central Office of Research Administration

Works on all regulatory aspects of research to ensure regulations are being met

Serve as single contact person for regulatory support of CORA for principal investigators sponsors IRB and contract research organizations

Assist physicians in writing and editing investigator initiated research protocols

Ensure protocols amendments adverse event reports investigational drug brochures continuing reviews and other documents are written appropriately submitted and approved by the IRB hospital departments and committees federal and regulatory oversight groups

Review research protocol and prepare study specific consent forms

Prepare documents needed to obtain approvals

Prepare maintain research records and files in concert with regulatory requirements and CORA files

Participate in special projects events promoting clinical trials to SLH

Qualification

Regulatory complianceClinical trial administrationProtocol writingResearch documentationCommunication skills

Required

3-5 years of experience

Bachelor's Degree

Preferred

3-5 years of experience preferred

Company

Saint Luke's

Glassdoor3.8

About Saint Luke’s Saint Luke’s serves the West Region of BJC Health System as a faith-based, nonprofit, aligned health system committed to providing the highest levels of excellence in compassionate health care and health-related services.

Founded in 1882

Kansas City, Missouri, USA

10001+ employees