Clinical Trials Regulatory Specialist

Location: Health Sciences Center

Time Type:

Full time

Worker Type:

Regular

Job Req ID: R100127

Minimum Requirements:

Bachelor's degree in a related field and two years of regulatory experience.� Additional experience may be used on a one-to-one basis to offset the educational requirements.�

Position Description:

The Clinical Trials Program of the Brown Cancer Center is seeking a Regulatory Specialist 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).

Preferred Qualifications: Certification from Society of Clinical Research Associates.

The Brown Cancer Center encourages candidates to apply who have demonstrated capacity to create inclusive work environments, will work effectively on increasingly diverse teams, and will serve the increasingly diverse students we admit and want to attract.

Target Compensation Maximum:

Target Compensation Minimum:

Compensation will be commensurate to candidate experience.

Equal Employment Opportunity

The University of Louisville is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, sex, age, color, national origin, ethnicity, creed, religion, disability, genetic information, sexual orientation, gender, gender identity and expression, marital status, pregnancy, or veteran status. If you are unable to use our online application process due to an impairment or disability, please contact the Employment team at employment@louisville.edu or 502.852.6258.

Assistance and Accommodations

Computers are available for application submission at the Human Resources Department located at 215 Central Avenue, Ste 205 - Louisville, Kentucky 40208.

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.