Clinical Research Coordinator V

ULSA University of Louisville; United States; On-site; USD 75,000 - 95,000; Full time

Job summary

The University of Louisville Health Sciences Center, Department of Surgical Oncology, seeks a Clinical Research Coordinator V to oversee enrollment, accrual and daily trial operations. Reporting to the principal investigators, you will coordinate multiple protocols, ensure IRB/FDA/OHRP compliance, and maintain data quality while supporting participants and the research team.

This full-time, salaried position offers growth in a collaborative environment and requires strong regulatory knowledge

Responsibilities

• Coordinates the activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
• Ensures assigned studies are conducted in accordance with UL IRB, FDA and the OHRP.
• Reviews regulatory requirements to ensure proper methods, practices and procedures.
• Assists investigators and clinical staff in recruitment, screening and enrollment of eligible participants.
• Develops source materials and ensures compliance from site staff.
• Provides accurate data collection, entry and reporting in accordance with site SOPs and applicable regulations.
• Interfacing with research participants to determine eligibility and obtain informed consent.
• Communicates study requirements to the study team and oversight entities (IRB, sponsors, monitors).
• Provides ongoing quality control of study operations including maintenance of accountability logs.

Job description

Department: Health Sciences Center

Time Type: Full time

Worker Type: Regular

Grade 5 (Salaried)

Working under the direction of the clinical Principal Investigators (PI), in the Department of Surgical Oncology, the Clinical Research Coordinator V is responsible for the enrollment, active accrual, implementation, facilitation and coordination of daily clinical trials activities and plays a critical role in the conduct of multiple clinical research studies.

The Clinical Research Coordinator V works collaboratively with investigators, multidisciplinary clinical entities, sponsors, monitors and regulatory entities to ensure the safety of study participants, the efficiency of study operations and the timely completion of studies.

The Clinical Research Coordinator V is also expected to have an understanding of how regulatory, financial and oversight entities work together in the management of clinical research.

Essential Duties and Responsibilities

• Coordinates the activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
• Ensures assigned studies are conducted in accordance with the University of Louisville Institutional Review Board (UL IRB), Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP).
• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices and procedures.
• Assists investigators and clinical staff in the identification, recruitment, screening and enrollment of eligible study participants.
• Develops accurate source materials and ensures compliance from site staff.
• Provides accurate and timely data collection, documentation, data entry and reporting in accordance with site SOPs and applicable regulations.
• Interfaces with research participants to support efforts to determine eligibility and consent.
• Communicates and collaborates specific study requirements to study participants, the research team (PI, SI, data managers, regulatory, financial), the multidisciplinary clinical management team and oversight entities (IRB, sponsors, monitors).
• Provides ongoing quality control of study operations including maintenance of accountability logs.

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 [e-mail] or by phone [phone].

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