Senior Manager, Clinical Research Nursing (uofl)

Job Description

Department:

Location:

Health Sciences Center

Time Type:

Full time

Worker Type:

Regular

Job Req ID:

R106783

Minimum Requirements:

Master's degree in a related field and two (2) or more years of related experience including four years of clinical experience. Must have a Kentucky RN license in good standing. Additional experience may be used on a one-to-one basis to offset the educational requirements. Grade 10 (Salaried)

Position Description:

Under the guidance of the Director and other Clinical Trials Program ("CTP") managers and leadership, this position works collaboratively and proactively in alignment with the Mission of the CTP and Brown Cancer Center (BCC) to ensure the overall success of the clinical trials program of the BCC. This position manages the clinical conduct of a complex array of oncology and hematology treatment trials, involving multiple investigators, teams, sponsors, and departments.  This position is responsible for recruiting, hiring, orienting, training, supervising and mentoring clinical research staff for the CTP and monitoring the staff's workloads and adjusting work assignments, particularly in an environment of increasing numbers of complex treatment trials and increasing numbers of accruals.  The position must, in collaboration with the Director, Research and Support and the Education and Compliance Specialist, design, assess, and implement standards for the ethical conduct of clinical research, and develop and communicate policies and procedures to meet those standards.  This position works with BCC investigators and faculty to ensure studies are conducted according to study protocols, timelines, GCP and applicable regulations.  This position serves as an ex officio member of the BCC Clinical Trials committees such as the Clinical Scientific Review Committee (CSRC) and the Data and Safety Monitoring Committee (DSMC), including composing or updating the Committee's Plans, and ensuring coordination and effective administration of the committees’ activities. This position must be able to work collaboratively without "silos," and be able to propose and implement new initiatives. 

Essential Duties:

• Oversees and manages the daily activities of the BCC Clinical Trials Program clinical staff in conduct of a complex array of oncology and hematology research studies involving multiple investigators, study teams, sponsors and departments to ensure studies are conducted according to Good Clinical Practice, the protocol, and expected timelines.

• Manages a team of Clinical Research Coordinators and Research RNs through good management principles (e.g. best use of resources, continuous improvement, and ownership).

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• Recommends and carries out performance improvement plans, staff performance appraisals, and performs similar duties for all direct reports, including training for new employees and existing experienced staff.

• Plans, assigns, and evaluates the work of supervised staff while ensuring compliance with relevant credentialing agencies (Kentucky Board of Nursing, etc.).

• Assists in and/or leads the develops policies and procedures related to the effective management of the CTP, focusing on the clinical aspects and clinical staffing.

• Assists in the evaluation, development, and improvement of systems and processes.

• Collaborates with industry sponsors, colleague CTP managers, CTP leadership, and Principal Investigators to develop clinical trial programs that meet the needs of BCC patients and represents the BCC professionally to third parties.

• Collaborates with the Director, Regulatory Manager, and Education and Compliance Specialist to manage the intake and processing of new trials into the Cancer Trials Program “pipeline” and ensure that startup activities are completed in a timely manner.

• Ensures study teams are prepared for site initiation visits and opening trial enrollment.

• Serves on various clinical trial related committees of the Brown Cancer Center.

• Assists Education and Compliance Specialist in ensuring that staff are trained in the use of all software required for performing job duties and comply with all data requirements in collaboration with the CTP Systems Analyst.

• Stays current with clinical research regulation and compliance requirements, pursuing professional development opportunities for themselves and others as appropriate.

Preferred Qualifications:

• Existing SOCRA certification

• Master’s Degree in a relevant field (e.g., MSN, MBA, MPH, MA-BE, or MHA)

• Minimum of 5 years of clinical research experience in an oncology clinical research environment, including supervision of others (indirect or direct reports)

Target Compensation Maximum:

$124,200.00

Target Compensation Minimum:

$82,800.00

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.