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Position Description:

Under the direction of the Principal Investigator(s) in the Department of Surgery, the Clinical Research Coordinator II is responsible for participant recruitment, screening, informed consent, enrollment, and biospecimen collection for multiple clinical research studies. The Clinical Research Coordinator II works collaboratively with investigators, clinical care teams, laboratory personnel, and regulatory staff to ensure protocol compliance, participant safety, and the accurate collection, processing, documentation, and transport of clinical samples to designated research laboratories.

Essential Duties and Responsibilities

• Coordinates participant recruitment, screening, enrollment, and retention for multiple clinical research studies.
• Identifies and approaches potentially eligible participants in inpatient and outpatient clinical settings.
• Obtains informed consent and maintains ongoing communication with study participants throughout their participation.
• Collects, processes, labels, documents, stores, and transports biological specimens according to study protocols, institutional policies, and regulatory requirements.
• Maintains chain-of-custody documentation and ensures timely delivery of research specimens to designated Department of Surgery laboratories.
• Collaborates with investigators, clinical staff, laboratory personnel, and research teams to facilitate study enrollment and sample collection activities.
• Ensures assigned studies are conducted in accordance with University of Louisville Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP) guidelines, applicable federal regulations, and institutional policies.
• Maintains accurate and complete study documentation, source records, participant logs, and specimen tracking records.
• Performs data collection, data entry, and quality assurance activities in accordance with study protocols and established standard operating procedures.
• Assists with preparation and maintenance of regulatory documents, study files, and IRB submissions as needed.
• Communicates study requirements and participant schedules with investigators, research staff, and clinical teams to ensure successful study implementation.
• Supports monitoring visits, audits, and quality assurance activities by maintaining organized and compliant study records.
• Maintains inventory and supplies necessary for participant enrollment, specimen collection, processing, and storage.

Target Compensation Maximum:

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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.