Research Regulations Specialist II - R108570

Location: Health Sciences Center

Time Type:

Full time

Worker Type:

Regular

Job Req ID: R108570

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 Brown Cancer Center is seeking a Research Regulatory 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).

Essential Duties:

• 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.

• Certification from Society of Clinical Research Associates

Target Compensation Maximum:

$36.22

Target Compensation Minimum:

$24.13

Compensation will be commensurate to candidate experience.

Equal Employment Opportunity

The University of Louisville is an Equal Employment Opportunity employer. The University strives to provide equal employment opportunity on the basis of merit and without unlawful discrimination on the basis of race, sex, age, color, national origin, ethnicity, creed, religion, disability, genetic information, sexual orientation, gender, gender identity or expression, veteran status, marital status, or pregnancy. In accordance with the Rehabilitation Act of 1973 and the Vietnam Era Veteran Readjustment Act of 1974, the University prohibits job discrimination of individuals with disabilities, Vietnam era veterans, qualified special disabled veterans, recently separated veterans, and other protected veterans. The University acknowledges its obligations to ensure affirmative steps are taken to ensure equal employment opportunities for all employees and applicants for employment. It is the policy of the University that no employee or applicant for employment be subject to unlawful discrimination in terms of recruitment, hiring, promotion, contract, contract renewal, tenure, compensation, benefits, and/or working conditions. No employee or applicant for employment is required to endorse or condemn a specific ideology, political viewpoint, or social viewpoint to be eligible for hiring, contract renewal, tenure, or promotion.

Consistent with applicable law, demographic information is collected for aggregate reporting requirements. Demographic information provided through this application is not available to hiring managers/committees and is not considered in hiring or employment decisions.

Assistance and Accommodations

Computers are available for application submission at the Human Resources Department located at 2315 South First Street Walk, Room 02C - Louisville, Kentucky 40292.

If you require assistance or accommodation with our online application process, please contact us by email at employment@louisville.edu or by phone 502-852-6258.