Research Regulations Specialist II

Department: Health Sciences Center | Location: University of Louisville | Time Type: Full time | Worker Type: Regular

Minimum Requirements: Bachelor's degree in a related field and two (2) years of relevant experience or an equivalent combination of education and experience.

About the Role

The Clinical Trials Unit provides regulatory support and oversight to key research programs at the University of Louisville. The Research Regulations Specialist II is responsible for preparing research submissions to the IRB of record 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 individual will advise investigators on compliance and research logistics and planning.

Responsibilities

• Oversight and management of projects for the entire project period to ensure compliance with all applicable regulations, policies, and procedures.
• Evaluate the protocol and sponsor documents to determine if additional items are needed for IRB/Sponsor approval.
• Serve as the liaison with the sponsoring agency for regulatory approvals throughout the life of the project.
• Develop the regulatory and essential documents to be in compliance with the protocol and federal/local and affiliated healthcare provider requirements.
• Prepare consent and HIPAA documents with appropriate language representing the actual events that will occur as part of the research.
• 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 study team.
• Responsible for quality assurance for regulatory submissions for CTU and other departments.
• Conduct periodic assessments of submissions to identify exceptions in a timely manner.
• Oversee all federal and locally required regulatory documentation in a regulatory binder for each protocol.
• Participate in site qualification visits, site initiation visits, monitoring visits, and audits conducted by sponsor, FDA, healthcare providers, and IRB.
• Manage special projects as assigned, such as representing the Director of Clinical Regulatory Affairs in regulatory matters when needed, proposing corrective actions, policy revisions, data plans, and masking plans.
• Advise investigators on protocols and protocol ideas, compliance with University policy, and related aspects of conduct of clinical research.
• Educate departmental staff on regulatory affairs and provide guidance for documentation and process.
• Participate, support, and lead quality improvement projects.
• Develop and plan for program or protocol-specific corrective and preventative action plans.
• Write reports to internal and external agencies summarizing results of quality audit and compliance review.

Pay

Target compensation range: $24.74 – $37.13 per hour, commensurate with candidate experience.