MINIMUM REQUIREMENTS:

Bachelor’s degree in a related field and two (2) years of relevant experience or an equivalent combination of education and experience. Grade 5 (Hourly)

POSITION DESCRIPTION:

The Clinical Trials Program of the UofL Brown Cancer Center is seeking a Research Regulations Specialist II to provide regulatory support and oversight to clinical trials at the University of Louisville. This position is responsible for preparing research submissions to the IRB of record, maintenance of regulatory approvals and documentation, and providing regulatory guidance to the clinical and administrative staff of the Clinical Trials Program in a manner that demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA).

This position will provide regulatory oversight and management of human subject clinical trials for the entire project period to ensure compliance with all applicable regulations, policies and procedures as follows:

• Serve as primary regulatory contact with the sponsoring agency for regulatory approvals throughout the life of the project. Serve as primary regulatory contact to the University of Louisville IRB or other IRB of record for the clinical trial.
• Evaluate the protocol and sponsor documents such as lab and imaging manuals, case reports, consent forms, FDA correspondence to determine if additional items are needed for IRB/Sponsor approval.
• Develop site specific regulatory and other essential documents in compliance with the protocol and federal/local and affiliated healthcare provider requirements. Prepare consent and HIPAA documents with appropriate language for industry sponsor, facility, and IRB approval.
• Complete the electronic IRB submission, prepare IRB modifications based on analysis of contingencies presented by the committee or the study team, process sponsor requested changes and modify regulatory documents accordingly, manage essential documents in accordance with the sponsor, IRB and federal government requirements.
• Submit amendment and continuing review data on behalf of the Principal Investigator, investigate study irregularities and guide staff in reporting and documentation of events. Submit studies for closure and resolve any outstanding relevant findings with the sponsor or study team.
• Participate in study planning meetings, site initiation visits, monitoring visits and audits conducted by clinical trial sponsors, FDA, and IRB.
• Educate and provide guidance for documentation and processes to clinical trial site staff and investigators on matters of regulatory compliance, University policy, and Good Clinical Practice as relates clinical research conduct.
• Participate in internal quality audits, quality improvement projects, protocol specific corrective and preventative action plans, and compliance reviews for the Clinical Trials Program.

Preferred Qualifications:

• Certification from Society of Clinical Research Associate.

The Brown Cancer Center encourages candidates to apply who have demonstrated the capacity to create supportive work environments, collaborate effectively on teams, and serve the students we admit and aim to attract.

Please refer the Job description for details