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Working under the direction of the clinical Principal Investigators (PI), the Clinical Research Coordinator at the University of Louisville 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 research coordinator 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 research coordinator 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
• Assist 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
• Facilitates and documents the safe dispense and administration of investigation agents
• Facilitates and documents the safe use of investigation devices
• Reviews laboratory and clinical procedures including regular evaluations of protocol compliance.
• Conducts basic lab duties including procurement (including venipuncture), centrifuging, aliquoting, storage and shipment of study specimens

PREFERRED QUALIFICATIONS

• Bachelor’s degree in a scientific, informatics or health related field. 
• A minimum of 2 years’ work-related experience in a research, oncology or surgery
• Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
• Be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environments or have a willingness to learn and demonstrate proficiency within 6 months of hire
• Ability to manage multiple tasks simultaneously
• Immunizations according to CDC guidelines and facility policies.  Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
• Be available to respond to off hour (evening, nights, weekend) research needs and inquiries.
• Certification in research (CCRC), oncology (OCN) or surgery (CNOR).
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations, and an understanding of research procedures and the ability to function independently.
• Completion of CITI training (GCP, Human Subject Protection) and IATA shipping training
• American Heart Association Basic Life Support
• Prior laboratory experience including phlebotomy/venipuncture, sample processing and sample shipment.

Target Compensation Maximum:

Target Compensation Minimum:

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.