Research Regulatory Specialist

Saint Luke's Physician Group • Kansas City, MO

2d • Hybrid

About The Position

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. This is a Hybrid position located in the Kansas City ara. 3-5 years of experience preferred.

Requirements

• 3-5 years of experience preferred.
• Applicable Experience: 3-5 years
• Bachelor's Degree

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees