Clinical Research Nurse II

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Position Description:

The primary function of a Clinical Research Nurse II (CRN) is to coordinate clinical research studies conducted at the Brown Cancer Center for Oncology & Hematology, Radiation Oncology and Blood and Marrow Transplant patients. Clinical Research at the Brown Cancer Center includes early phase, novel treatment, multi-centered, cooperative and intergroup trials, multi-institutional pharmaceutical trials, and single- or multi-centered investigator-initiated trials.  The CRN facilitates compliances with the research protocol and Good Clinical Practice guidelines; uses multiple communication styles and methods to facilitate the effective coordination of clinical trials across disciplines and clinics, acting as a liaison between the principle investigator, sponsoring agent, study patients, referring physicians, pharmacist, statisticians and other members of the research team; takes leadership in ensuring an effective informed-consent process and study subject safety for the duration of the trial; ensures compliance with protocol procedures, assessments and reporting requirements; assists physicians in ensuring adequate source documentation and data-collection that validate the integrity of the clinical trial; assist in enhancing recruitment of study participants, helping with the design and implementation of  recruitment strategies for identifying and assessing patients who may be eligible for a clinical trial; and the CRN demonstrates leadership in adhering to ethical principles in the conduct of clinical trials in order to protect study subjects and data integrity.

Essential Duties:

• Coordinates all aspects of Tumor Infiltrating Lymphocytes (TILS) clinical research studies, in addition to other Cellular Cancer Immunotherapy and Solid Tumor clinical research studies as directed by the Senior Manager, Clinical Research Nursing. Coordinates all aspects of clinical trials initiation to ensure full compliance with sponsors and FDA, indirectly supervises data management with any aspect of protocol initiation coordination and data management (i.e., informed consent revisions, submissions to IRB, completion of research forms).

• Plans for patient recruitment methods. Screens potential patients to determine eligibility to include taking a current clinical history, reviewing patient records, assessing functional and physical status. Informs faculty of potential eligibility. Educates patients and family members regarding details of appropriate clinical trials available. Develops resources and materials for patient/family teaching.

• Coordinates logistics of patient visits, coordination of clinical activity including ordering/scheduling of all tests required for protocol, coordinates information between all parties for multi-modality protocols.

• Organizes protocol inservices for staff and data management to ensure staff understanding of specifics of each protocol. Provides inservices to department employees regularly on new studies and specific requirements for individual areas.

• Coordinates with medical staff to accurately reflect treatment orders for various protocols then follows the patient according to protocol schedules and data documentation. Evaluates toxicities and keeps investigators apprised of necessary modifications of each study.

• Assures all protocol data forms completed in an accurate and timely manner as described by protocol guidelines, including necessary case report forms, serious adverse events and submits to IRB, sponsors and FDA as required.

• Maintains high level of self-education to include multi-disciplinary conferences, semiannual meetings, professional oncology meetings, workshops and other learning opportunities appropriate to research methodologies. Maintains appropriate certifications

Preferred Qualifications:

• ACRP or SoCRA certification in Clinical Research, OCN

The Brown Cancer Center encourages candidates to apply who have demonstrated the capacity to create supportive work environments, collaborate effectively on teams, and serve the students we admit and aim to attract.

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 [email protected] or by phone 502-852-6258.